Assessment of the more suitable method for application of lignocaine to throat and airway to reduce pain and discomfort during bronchoscopy procedure in children, among nebulization of lignocaine and application of lignocaine directly through bronchoscope.

Not yet recruiting

• Conditions: Children already selected for flexible bronchoscopy due to a medical indication as already decided by the professor of the division of paediatric puomonology of the institution.

• Registration Number: CTRI/2016/09/007327
• Lead Sponsor: All India Institute of Medical SciencesDelhi

Brief Summary

**INTRODUCTION**

Flexible bronchoscopy is the goldstandard tool to visualize both upper and lower airway in human (1). Hence, itspopularity in the assessment of airway has increased gradually and now it hasevolved into an essential diagnostic and therapeutic modality in the field ofpulmonology (2). In addition, advancement of technology and physician’sexperience with this tool has established it as a safe procedure with very lowmortality and minimum morbidity (3). The feasibility of flexible bronchoscopyin infants and small children was first described in 1978 (4). Since then theutility of flexible bronchoscopy in children also shows a rising trend (5).

However, introduction of a bronchoscope aforeign body, through the airway is an invasive procedure. It would be anunpleasant and painful experience for the patient. It is also potential to stimulateprotective airway reflexes like cough. In addition, it could induce vagalstimulation leading to laryngeal spasms, bronchospasms and bradycardia (6). Hence,provision of an adequate level of anaesthesia to the patient’s airway is a mustfor a successful bronchoscopy. This requirement is more highlighted inpaediatric practice because a bronchoscopy with inadequate level of anaesthesiamight be a huge trauma to children.

Due to all these reasons, paediatricflexible bronchoscopy in children was usually done under deep sedation orgeneral anaesthesia during the early part of its introduction (7). In contrast,the use of conscious sedation and adequate tropical anaesthesia to airway havetaken the bronchoscopy procedure out from the operating theatre and now it isan outpatient procedure which is done at a day care setup in most centres aroundthe world(7). Introduction of a bronchoscope through the airway, especiallythrough the larynx is a strong stimulus to arouse a sedated child. Therefore,application of an adequate tropical anaesthesia to the airway is the key to asuccessful bronchoscopy which is done under sedation. (8) It also abolishlaryngeal reflexes and gaging which finally ensure patient’s as well as physician’scomfort during the procedure (9).

Lignocaineis the most commonly used medication for the topical anaesthesia of airway, notonly for bronchoscopy but all procedures involving the airway (10). Althoughthere is no controversy regarding the use of lignocaine in bronchoscopy as atopical anaesthetic agent, there is no consensus about the mode ofadministration. Direct administration of lignocaine to the airway via workingchannel of the bronchoscope in “spray as you go†fashion is the commonlypractising procedure (11). This might lead to a potentially toxic level oflignocaine in serum (12,13). Similarly, direct application of a liquid to un*anaesthetised*larynxmight produce intense cough and vagal stimulation (8).

Nebulization of medications are commonly practice inchildren and generally it is well tolerated. Nebulization of lignocaine priorto the procedure might deliver the drug to upper as well as lower airways without inducing gag reflex. Then thebronchoscope can introduce in to an already anaesthetized airway. Additionaldoses could be instilled while going in if it is required. Studies in adultshave shown that nebulized lignocaine produce similar anaesthetic effect incomparison to local instillation method and more patient tolerance andacceptance (14,15,16). Nebulized lignocaine might have equivalent or morebenefits in comparison to routine direct instillation technique in childrenalso.

**REVIEWOF LITERATURE**

Since the introduction of flexible bronchoscopy inpaediatric practice, almost four decades have elapsed now (4). The use of thistool has extended the diagnostic as well as therapeutic capabilities ofphysicians in a wide spectrum of respiratory disorders in children. Now it is aroutine practice in every paediatric pulmonology unit. However, still there isno consensus about the sedation and mode of topical anaesthesia for paediatricbronchoscopy in children(17).

Lignocaine which ischemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-,monohydrochloride is the most commonly used drug for thetopical anaesthesia of airway  due to itsrapid onset and relatively shorter duration of action and lesser toxicity incomparison with other medications (18). Lignocaine inhibits the ionic fluxes required for the propagation ofimpulses (initiation and conduction) and hence,stabilizes the neuronal membranes, producing alocal anaestheticaction (19). Lignocaine is metabolized by theliver rapidly. Its metabolites and unchanged molecules are excreted by kidneys. The elimination half-lifeof lignocaine is about 2 hours (19). Life-threateningand fatal events havebeen reported in infants and young childrenwith the use high or more frequent doses of lignocaine. Even though, it has apotential to induce cardiac arrhythmias, seizures and even cardiac arrest, thecautious use of recommended doses with adherence to guidelines reported to besafe in routine practice because its toxicity is directly related to its serumlevels (11). A plasma level above 5 µg/ml which usuallyachieved with a dose more than 8.2mg/kg is considered to be toxic (20).

Lignocaine israpidly absorbed to the systemic circulation following the administration toairway locally (11). Few studies were found which assessed the safety and serumlevels of lignocaine after local application to the airway in adults andchildren.

In one study toassess the serum levels of topical lignocaine in fibre optic bronchoscopy Sucenaet al demonstrated that even some patient’s serum levels have exceeded thetoxic levels they did not show any adverse effect (20). Serial blood sampleswere taken before and after the administration of lignocaine as 2% gel, 10%spray and 2% liquid respectively during the procedure (cumulative dose of 11.6 +/- 3.1 mg/kg). Six out of 30 participantsshowed higher serum levels than the toxic level but without any untoward effects.Hence, the author suggested that even higher doses of topical lignocaine wouldbe safe in flexible bronchoscopy. Similarly, Loukideset al demonstrated that although the total dose of local lignocaine used in thestudy has exceeded the recommended highest dose in all 12 adult participants, noneof them reached the toxic serum level and no one developed an adverse effect duringthe flexible bronchoscopy (21). They also demonstrated that peak plasmalignocaine concentration could be achieved within 20-30min of administration.However, the study population was only 12. Therefore, the applicability of thisstudy to practical setup is limited.

 Efthimiou et al also studiedthe plasma concentration of lignocaine during the fibreoptic bronchoscopy (22).They recorded lignocaine concentration of 41 adult patients who receivedtropical application during fibreoptic bronchoscopy. Average total dose of  9.3 +/- 0.5 mg/kgwas used. All achieved adequate level of anaesthesia and mean plasmaconcentration reached was 2.9 +/- 0.5 mg/l. All patients including 2 who haveexceeded the toxic level did not show any complication. This study alsodemonstrated that peak plasma concentration depends only on the mg/kg dose.Other factors which might influence the mucosal absorption like airflowobstruction, sputum production and smoking did not show any significantassociation. Similar observation published by Milmanet al in 1998 after studding the serum lignocaine concentration duringfibreoptic bronchoscopy of 16 patients (23). Total dose of lignocaine 2.4-8.0mg/kg were used, including nebulized dose1.6-6.6 mg/kg. Serum lignocaine concentrationwas correlated only with the total mg/kg dose and no complications weredetected. This team of investigators also concluded that lignocaine could be used safely as a local anaesthetic agent for flexible bronchoscopy with atotal dose which maintaining below 6-7 mg/kg body weight.

Scieszka et alstudied the serum level of lignocaine following nebulization via a highfrequency jet ventilator during flexible bronchoscopy (24). All 12 adult participantsachieved adequate level of anaesthesia while, none of them developed untowardeffects and none of them required additional lignocaine doses. Therefore, thisteam concluded that nebulized lignocaine is also effective and safe forflexible bronchoscopy.

Amitai et alstudied the serum lignocaine concentration during flexible bronchoscopy inchildren and published the results in 1990 (25). In this study, lignocaine wasgiven to the airway via bronchoscope. Serial blood samples were drawn to assessthe lignocaine serum concentration in 15min intervals. 15 children (3months –9.5year) were participated and total lignocaine dose was ranged from 3.5 to8.5mg/kg. Peak serum lignocaine concentration was 1-3.5µg/ml and it was wellcorrelated with the total lignocaine dose. Despite, some children exceeded thetotal recommended dose and potential toxic serum level, none has developed acomplication. Hence, they concluded that the use of tropical lignocaine up to8.5mg/kg appear to be safe in children. Gjonaj et al also did a similar kind ofstudy to assess lignocaine concentration during flexible bronchoscopy inchildren. However, in this study nebulized lignocaine was used instead ofdirect local application through the bronchoscope (11). In this prospectiverandomized double blind study 20 children (1.5 – 192 months) received either4mg/kg or 8mg/kg dose of lignocaine via a nebulizer. Intravenous midazolam andadditional doses of lignocaine via bronchoscope were given while doing theprocedure by a blinded bronchoscopist if it was needed. Fifty percent ofchildren in both groups tolerated the procedure only with nebulized lignocaineand they did not require any additional doses via bronchoscope. The highestserum level of lignocaine achieved following nebulization was 0.62µg/ml, alevel far below the toxic level. The supplemental lignocaine which needed was1.2-3.3mg/kg in 4mg/kg nebulized group and 1.8-11.6mg/kg in 8mg/kg nebulizedgroup. However, none has developed a feature of lignocaine toxicity.Furthermore, those children also did not develop any adverse effect likebronchospasms due to the use of nebulized route. Finally, the authors concludedthat nebulized lignocaine up to 8mg/kg doses appears to be safe in paediatric flexiblebronchoscopy and it was moderately effective as a tropical agent in anaesthesiafor this procedure.

The safety oflignocaine as a topical anaesthetic agent for flexible bronchoscopy in bothadults and children has been proven objectively by many studies and few of themhave mentioned above. Lignocaine topical application to achieve anaesthesia forbronchoscopy could be done in several ways. Direct tracheal injection throughcricothyroid membrane, local spray to pharynx and larynx with the use of aplastic cannula, local application of lignocaine as a gel, direct applicationof the liquid form in to airway through the working channel of bronchoscope in“spray as you go†fashion and nebulization of the medication via a jet orultrasonic nebulizer are the mostly used methods (26). Each of these method hasits own advantages and disadvantages. There were some studies done to assessthe effectiveness of lignocaine as a topical anaesthetic agent, while, theyalso compared the effectiveness of different modalities of local application oflignocaine. Most of these studies done in adults.

Stolz  et al did aprospective, double blind, randomized controlled trail to evaluate theadditional benefits of nebulized lignocaine in flexible bronchoscopy. Onehundred and fifty adult patients were participated in this study (26). Patientswere sedated using intravenous hydrocodone and midazolam boluses. All receivednebulization of either 4 mL of 4%lignocaine or 4 mL of normal saline as a placebo. Both groups received 10%lignocaine spray to nasopharynx 4times and to oropharynx 2times. Additionallignocaine doses were given through the bronchoscope while doing the procedureas decided by the bronchoscopist. Following the procedure both bronchoscopistand patient gave a rating for their perception of cough during the procedure usinga 100mm visual analogue scale. There were no difference in cough scores of bothphysician and patients in both groups. Other outcome parameters like durationof procedure and haemodynamic findings were also similar in both groups. Meanlignocaine dose used for the nebulized group was significantly higher than theplacebo group. Therefore, additional nebulized lignocaine for flexiblebronchoscopy under combined sedation was not recommended by the authors. It seemsthat a significant level of anaesthesia in the upper airway has been achievedwith 10% lignocaine spray in both groups during this study. Hence, the placefor additional nebulized lignocaine has dropped. However, in paediatricpractice local spray of lignocaine to nasopharynx and oropharynx cannot beachieved as in adults because this need a very good patient cooperation. It isvirtually impossible in small children and infants as they are unable to keeptheir mouth open according to instructions until local spray is being carriedout. Therefore, in children still there would be a place for nebulizedlignocaine.

There are some studies in adults which proved theeffectiveness of nebulized lignocaine as similar as the local instillation viabronchoscope. Perhaps, more patient satisfaction was achieved with thenebulized route. The tendency to stimulate cough while instilling a liquiddirectly in to highly innervated larynx might be the reason for this. Isaac PAet al did a single blinded study to compare the effectiveness of nebulizedlignocaine via an inexpensive and portable jet nebulizer with other two methodof local lignocaine application namely, cricothyroid puncture and directinstillation through bronchoscopy (27). The main outcomes of the study,physician’s and patient’s assessment of the overall condition of the procedurewere done using a 100mm visual analogue scale. Nebulization method was usedsuccessfully in 46 of 48 (96%) patients. The cricothyroid injection hasproduced better condition than nebulization. However this method is notpractising in children. Nebulization method was as satisfactory as localinstillation method. Nebulization was safe, effective and both bronchoscopistand patient accepted it well. No adverse effects were recorded even thoughhigher than the recommended dose was used in some patients. Keaneet al also did a similar kind of study to compare the efficacy of nebulizedlignocaine with local spray technique (14). All 54 adult patients received 100mgof lignocaine either via nebulization (2.5ml of 4% solution) or via a standardspry device (10mg/spray in 10 times). All patients received additional total100mg of lignocaine to the vocal cords, trachea and main bronchi viabronchoscope. Cough frequency which assessed after listening to an audio recordof the procedure was the main outcome. No significant difference was observedin overall cough frequency of both groups. However, most patients in spry groupreported that the spray was unpleasant. Therefore the investigators concludedthat nebulized lignocaine as effective as local spray in flexible bronchoscopyand patient preference towards the nebulized route.

Korttilaet al compared the ultrasonic nebulizer andlaryngotracheal administration of lignocaine for bronchoscopy under conscioussedation (15). Bronchoscopist rated the adequacy of local anaesthesia andpatient cooperation using a 100mm visual analogue scale. Both ratings were higherin the local spray group. Peak plasma concentration of lignocaine achievedearlier in nebulization group and it was lower than the local spray group. Eventhough, the ratings were higher for local spray group, nebulized group alsoachieved adequate anaesthesia to carry out the procedure and no adverse effectswere recorded. Hence, the study group concluded that bronchoscopy can beconducted using nebulization as successfully and safely as local spray oflignocaine. Nebulization route would be more important in children becauselocal spray in to larynx is not feasible, especially in younger ones. Asomewhat similar kind of study was done by Giriraj et al in 2014 to assess the effectiveness of nebulized lignocaineas a topical anaesthetic agent in diagnostic transnasal tracheoscopy, a similarprocedure as flexible bronchoscopy done by ENT surgeons (14). A retrospectivechart review and prospective case series were used. Eight patient received bothmodalities in two different occasions. 11 of 16 patients (69%) who received localinstillation of lignocaine to the larynx via the working channel oftracheoscopy resulted in strong cough, whereas, 98% of patients who receivednebulized lignocaine have completed the procedure comfortably. 100% of patientswho have the experience of both modalities preferred local anaesthesia withnebulizer alone. Gove et al compared the use of nebulized lignocaine with localinstillation in fibreoptic bronchoscopy under conscious sedation in 1985(28).The authors noted that nebulized lignocaine alone could be used forbronchoscopy because it provided adequate level of anaesthesia and procedurewere performed more quickly. They finally concluded that nebulized lignocainealone or with diazepam premedication is effective, safe and acceptable method ofinduction of topical anaesthesia for flexible bronchoscopy. Kaur et al demonstrated that with the use ofnebulized and local spray of lignocaine prior to the procedure, there were nosignificant difference between the effectiveness of 1% or 2% lignocaine instillationduring the procedure to achieve topical anaesthetic effect during flexiblebronchoscopy (29). Hence, when combined with prior nebulization, 1% lignocainewould be sufficient to achieve adequate level of anaesthesia instead of using2% solution.

Asystemic review done by Mihara et al in 2014 demonstrated that topicallignocaine reduce the possible laryngospasms in children during upper airwayprocedures (30). However, Nielson  et al. demonstrated that direct application oflignocaine solution in to larynx might affect the assessment laryngomalacia inchildren during flexible bronchoscopy because, it induce increase in signs oflaryngomalacia (31). Hence, local lignocaine might exaggerates the clinicalfindings of laryngomalacia during bronchoscopy.

Even tough, there is no consensus about the safedose of lignocaine for topical anaesthesia of the airway, 4mg/kg is generallyconsider as the cut off. However, in practical setup this dose limit is usuallyexceeding and up to 8mg/kg proven as safe (10).

**RATIONALEOF THE STUDY**

Nebulization of medications believed to produce moreeven and through application of medication along the entire mucosa of theairway. Even if it is an off labelled use, the safety and effectiveness ofnebulized lignocaine as a mode of topical anaesthesia in flexible bronchoscopyhas been proven (32). Even though, one of the primary objective of usingtopical lignocaine during bronchoscopy is to reduce cough, direct applicationof liquid form in to unanaesthetised highly innervated airway itself potentialto induce intense cough. In addition, assessment of some conditions likelaryngomalacia might be adversely affected by direct local instillation. However,nebulization of the medication likely to be less irritant to the mucosa of theairway in comparison to the direct tropicalization via bronchoscope (10). Mostof the adults preferred nebulization route than direct local instillation routein above mentioned studies. As nebulized medications are frequently used inchildren and it seems well tolerated by them, nebulized lignocaine also couldbe used in children undergoing flexible bronchoscopies under conscioussedation. This might enhance the topical anaesthesia in nasal passage, larynx,trachea and bronchi at the same time. Common practices which done in adults, priorto the bronchoscopy procedure to achieve topical anaesthesia, like tropicalapplication of lignocaine gel in to nasal passage and spray of lignocaine topharynx and larynx are not feasible in children as this need good patientcooperation. Perhaps, that kind of measures might scare children more. On theother hand, prior preparation of children with nebulized topical anaesthesia atthe bedside, before sending to the bronchoscopy suite might reduce thecumulative time taken for the procedure. Due to all these reasons, there wouldbe a place for nebulized lignocaine as a topical anaesthetic agent for flexiblebronchoscopy done in children under conscious sedation. Hence, assessment ofthe effectiveness of nebulized route in comparison to the routine localinstillation through the working channel of the bronchoscope “spray as you gofashion†would be important. Unfortunately, no study was found which comparedthese two methods in children indicating a gap in knowledge of this field.Therefore, we planned a randomized open labelled control trail to compare thesetwo modalities of lignocaine tropicalization in paediatric flexiblebronchoscopy.

**RESEARCH QUESTION:**

•      Is nebulized lignocaineefficacious topical anaesthetic agent in paediatric flexible bronchoscopy doneunder conscious sedation when compared to conventional locally instilled lignocaine directly through the bronchoscope in a "spray as you go" fashion?

**HYPOTHESIS:**•      Nebulized lignocaine is notinferior to locally instilled lignocaine directly through the bronchoscope in a "spray as you go" fashion, as atopical anaesthetic agent in paediatric flexible bronchoscopy done underconscious sedation.

**PRIMARYOBJECTIVE** •      To compare the efficacy ofnebulized lignocaine and locally instilled lignocaine directly through thebronchoscope in a "spray as yougo" fashion, as a topical anaesthetic agent in flexible bronchoscopy doneunder conscious sedation in children aged 1moth to 16 years.

**SECONDARYOBJECTIVES-**

•      To compere the following parameters to assess the safetyand easiness of the procedure while using these two modalities of topicalanaesthesia.

Patient’s safety

•     Intensity of coughand stridor which developed or worsened due to the procedure

•     Adverse eventsduring the procedure (Oxygen desaturations, Tachy or Bradycardia)

•     Total dose oflignocaine used for the procedure

•     Need of top updoses of sedative drugs and cumulative dose of each medication used during thewhole procedure.

•     Olderchildren’s (more than 5y) felling about the maximum pain they perceived duringthe procedure.

Easiness of the procedure

•      Time taken to enter in to the lower airway throughlarynx

•      Total duration of the procedure

•      Physician’s and bronchoscopy nursing sister’soverall felling about the easiness of the procedure

**OUTCOMEMEASURES**

• **Primary Outcome**

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| Objective

To compare the efficacy of nebulized lignocaine and locally instilled lignocaine directly through the bronchoscope in a "spray as you go" fashion, as a topical anaesthetic agent in flexible bronchoscopy done under conscious sedation in children.

|Outcome

Frequency of the child’s cough during the procedure (Number of cough episodes per a minute)

| Measure

Count the number of time child cough during the procedure by watching a video record of the procedure. It will be divided by total time of the procedure to get rate.

 **SecondaryOutcomes**

**1.Patient’s safety**

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|**Outcome**

**Measure**

|Intensity of the cough

The blinded observers who count the frequency of cough will give a rating regarding the intensity of the cough using a 100mm VAS after watching the video recording.

|Intensity of stridor which developed or worsened due to the procedure

Same observers who count the frequency of cough will also give a rating regarding the intensity of the stridor using a 100mm VAS after watching the video recording.

|Desaturations during the procedure (SaO2 drop >5% from Baseline)

Document SaO2 before nebulization and continuous monitoring of SaO2 during and up to 1 hour after procedure with a pulse oxymeter. Total duration of desaturation >5% from baseline is measured in seconds using a stop watch

|Minimum O2 saturationdetected during the procedure and the percentage dropfrom baseline.

Minimum SaO2 during and 1h following  the procedure is documented and percentage drop from baseline value will be calculated

| Haemodynamic stability-Maximum drop in pulse rate

Minimum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)

|Haemodynamic stability Maximum rise in pulse rate

Maximum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)

|Haemodynamic stability Maximum fluctuation of pulse rate

Difference between maximum and minimum pulse rate (Expressed as percentage deviation from baseline value)

|Total dose of lignocaineused for the procedure

Cumulative dose of lignocaine used in the procedure. (Expressed as mg/kg)

|Total dose of sedative medication (midazolam)used for the procedure

Total dose of midazolam including top ups during the procedure. (Expressed as mg/kg)

|Older children’s overall perception of the maximum pain during the procedure.

 Wong-Baker FACES® Pain Rating Scale will be given to children >5y to rate their feeling of pain during the procedure (2h after the procedure or when they are fully awake, whichever comes last)

 **2.Easiness of the procedure**

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|**Outcome**

**Measure**

|Time takento enter in to the lower airway through vocal cords

 Time from insertion of the tip of the bronchoscope to a nostril to insertion of bronchoscope through the vocal cords. Directly measured with a stop watch. Expressed in seconds.

|Total durationof the procedure

Time from insertion of the tip of the bronchoscope to a nostril to removal the tip of the bronchoscope from the nostril after fully completion of the procedure.

Directly measured with another stop watch. Expressed in seconds

|Bronchoscopist’s and bronchoscopy nurse’s overall feelingabout the easiness of the procedure

Physician who did the bronchoscope and nursing sister who assisted for the procedure will give an overall rate about the easiness of the procedure using a 100mm VAS within 15min after completion of bronchoscopy.

 **METHODOLOGY**

**Study design:** Randomized open labelled control trial

**Study period:** July 2016 to January 2017

**Place of study**:  Bronchoscopysuite, Division of Pediatric Pulmonology, Department of Pediatrics, All IndiaInstitute of Medical Sciences, New Delhi

**Study population:** Children aged 1 month to 16 years with respiratorydiseases, who have an indication for a flexible bronchoscopy as already decidedby the   in-charge consultant paediatricpulmonologist of the unit.

 **Inclusion criteria:**

Children aged 1 month to 16y with respiratory diseasesand already selected for a flexible bronchoscopy under conscious sedation atthe paediatric bronchoscopy suite, AIIMS. No healthy volunteer will be included.

**Exclusion criteria:**

1. History of any kind of adverse reaction to lignocaine given by any route

2. History of any adverse reaction to any other medication which use in the procedure (Atropine, Midazolam, Fentanyl)

3. Children who are already given sedative drugs or lignocaine within 72hours of the procedure.

4. Children who are already on ventilatory support via ETT or tracheostomy

5. Children with SpO2 <92% with 5l/min O2 at the time of enrolment

6. Children with GCS <15/15 at the time of enrolment, due to any reason

7. Already diagnosed children with cardiac arrhythmias

8. Already diagnosed children with acute or chronic, liver or renal failure

9. Not consented

 **PATIENT ENROLMENT**:Childrenwho are followed up at out patient’sclinic will be admitted to C5 day care unit for bronchoscopyonthe day of the procedure, if they were selected for a bronchoscopy by thein-charge consultant paediatric pulmonologist of the unit if there is a medicalindication.

Bronchoscopywill be done in some children who are on inward treatment at AIIMS if there is an indication.

First,all these children will be assessed with a routine bronchoscopy check list of the unit according to the unitpolicy to confirm the fitness and preparation for the procedure at the day ofthe procedure (annexure-01).  Bronchoscopywill be done only in children who fulfil the criteria according to thatchecklist and those who have been selected will be evaluated for the enrolment.All children of 1month to16years, who have been selected for bronchoscopy will be evaluated with a preprepaid enrolment form (annexure-02) to assess the eligibility for the study.Children who fulfil any exclusion criteria will be excluded.

If the patient is eligible, parent’s information sheetwill be given (Annexure-03) and informed written consent (Annexure-04) will betaken from parents by the chief investigator.  Consented children will be enrolled to thestudy.

**RANDOMIZATION**Computer generated Variable Blockedrandomization will be used to allocate equal number of children randomly forboth arms of the study. Randomization will be performed by a person notinvolved in the study.

**ALLOCATIONCONCEALMENT**

Sequentiallynumbered opaque envelopswillbe used for allocation concealment. Each patient will begiven a serial numberaccordingto the order of enrolment. All the envelopes will be kept inside the bronchoscopyroom in a locker and envelopes will be taken out according to the serialnumber. The allocated envelop to a particular serial number will be opened bythe bronchoscopy nurse and randomly allocated study arm of that particularserial number will be disclosed to the in charge senior resident forbronchoscopy on that day.

As one arm use nebulization and theother arm use local instillation of liquid form through the bronchoscope, theproject will be carried out as an openlabelledstudy. Local instillation of N.saline alone in to larynxas a placebo in nebulization arm might induce intense cough and nebulization ofN.saline alone as a placebo in local instillation arm might produce,bronchospasms. Hence, a use of a placebo to facilitate blindness was notconsidered.

**INTERVENTION**

**Arm01 :**  Nebulization of 4mg/kg lignocaine 15min priorto bronchoscopy + IVAtropine 0.01mg/kg,  IV Midazolam0.1mg/kg and IV Fentanyl  2 µg/kg +  (Additional Midazolam 0.1mg/kg + additionalLignocaine 1mg/kg local instillation via bronchoscopy 1-2 times if required)

**Arm-02:**IV Atropine 0.01mg/kg,  IV Midazolam0.1mg/kg and IV Fentanyl  2 µg/kg + Localinstillation of lignocaine 2mg/kg via bronchoscope to larynx + 2mg/kg atcarina. +  (Additional Midazolam 0.1mg/kg+ additional Lignocaine 1mg/kg local instillation via bronchoscopy 1-2 times ifrequired)

**PROCEDURE:**

First, children at day care orpaediatric ward who are already prepared for the bronchoscopy will be assessedagain with the routine bronchoscopy check list of the unit to confirm thepreparation and suitability for the procedure on that day. Then children whohave been selected for bronchoscopy, will be assessed with the enrolment formto select them for the study. Parents of the children who do not meet theexclusion criteria will be explained about the study and consent form will begiven by the chief investigator. If parents give the informed written consentfor the participation, children will be enrolled to the study. Once a patientis enrolled a serial number will be given according to the order of theenrolment.

The envelop which is already allocatedto child’s serial number will be opened by the bronchoscopy nurse and randomlyallocated study arm for that particular child will be revealed to the in chargesenior resident for bronchoscopy on that day.

Then child’s pulse rate, respiratoryrate and SpO2 on room air or with O2 <5l/min will be recorded at thebedside. (Children with SpO2 <92% with 5l/min O2 already excluded from thestudy). Presence of stridor before the procedure will be recorded. Children whohave been randomly allocated to the nebulization arm will be nebulized withlignocaine 15min priortothe procedure at bedside using a jetnebulizer and appropriate sized well-fitting face mask according to the age.

Lignocaine dose for nebulization will be4mg/kg and 2% lignocaine solution(20mg/ml) will be used. The dose for a 10kg child will be 2ml. The minimum doseused in the study will be 1ml and maximum dose will be 5ml of 2% lignocainesolution. (All children below 5kg receive 1ml and all children above 20kg willreceive 5ml of 2% lignocaine solution. Children between 5-20kg will receive1-5ml of 2% lignocaine solution according to the weight). Nebulized salbutamolsolution 0.1mg/kg also will be added to the nebulizer in children who has ahistory of wheezing. Then, normal saline up to 4ml will be added if necessary tomake the final volume of nebulization solution 3ml for children below 10kg and 5mlfor children above 10kg to facilitate effective nebulization through the jetnebulizer. Total time for nebulization expected to be 10-15min. Followingnebulization, children will be shifted to the bronchoscopy suite whichis situated in the same floor of the same premises of paediatric ward and daycare.

Children who have been randomly allocatedto local instillation arm will be nebulized with 0.1mg/kg salbutamol solutionif there is a history of wheezing 15min before sending to bronchoscopy suite.(Nebulization of salbutamol for children with a history of wheezing before theprocedure is a routine practice of the unit). Other children who does not havea history of wheezing and have been allocated randomly to study arm-02 will be sentto the bronchoscopy room directly without any prior medication. All thesechildren’s pulse rate, respiratory rate and SpO2 on room air or with O2<5l/min, presence of stridor will be recorded at the bedside before sending.

At the bronchoscopy room child’s pulserate, respiratory rate, SpO2 and presence of stridor will be documented again. Childwill be connected to a pulse oxymeter and monitoring continued throughout theprocedure and 2h following the procedure or till child become fully awake, whichevercomes last. Then all the children in the study (both arms) will receive followingmedications to achieve conscious sedation. IV- Atropine 10µg/kg, IV-Midazolam 0.1mg/kg, IV-Fentanyl 2µg/kg respectively.All the IV injections will be followed by a flush with 1-2ml N. Saline. Closureof eyes will be considered as the sign of sedation. Usually children achievesedation with this combination. If child does not sleep 3min after IV fentanylinjection, IV-Midazolam 0.1mg/kg will be repeated. If child wakeup during theprocedure, an additional midazolam 0.1mg/kg will be used. All the used drugswill be recorded and final total dose will be calculated.

Child will be continuously monitoredusing a pulse oxymeter as mentioned above. All the medications and equipment requiredfor an emergency resuscitation will be kept in the bronchoscopy room. All themedical staff working in the bronchoscopy room have completed the PaediatricLife Support Course and competent in resuscitation of children if they developany complication due to medications or procedure.

Lignocaine solutions for mandatoryinstillation in study arm-02 and additional instillation, if it is required inboth arms will be prepared before the procedure and will be kept in labelledsterile syringes separately. For a patient in study arm-2, two aliquots of2mg/kg lignocaine and additional 2 aliquots of 1mg/kg will be prepared. For a10kg child, 2 aliquots of  2% lignocainesolution 1ml and 2 aliquots of 2% lignocaine 0.5ml will be taken and alldiluted 1:1 with normal saline. For study arm-01, only 2 aliquots of  1mg/kg lignocaine solution (2% lignocaine 1:1diluted with normal saline) will be prepared and will be kept in labelledsterile syringes separately.

A free flow of O2 5l/min willbe given to all children throughout the procedure despite their preprocedure O2saturation values. Once the child sleeps (indicated by eye closure) andmaintain SpO2 >92% with spontaneous respiration and HR >60/minbronchoscopy procedure will be started. A video camera will be started torecord child’s cough. This camera will be focussed only to child’s face andhence, use of medications during the procedure will not be recorded to maintainblindness during the assessment of cough frequency later. The camera will bekept in the same place for all procedures and the bronchoscopy bed also will bekept in the same place for all procedures. Same video camera and same settingswill be used for all recordings.       4%lignocaine gel will be applied to the distal 10cm of the bronchoscope prior toinsertion in both arms of the study to facilitate the passage through theairway. Nasal route will be used to advance the bronchoscope. Two stop watcheswill be activated once the tip of the bronchoscope inserted to a nostril of thechild to advance it through the airway. One will be stopped when tip of thebronchoscope advance through the vocal cords and other will be stopped when tipof the bronchoscope remove from the nostril after completion of wholeprocedure. Both times will be recorded and those will be taken as the timetaken to advance the bronchoscope through larynges and total duration of theprocedure respectively.

Once the bronchoscope is advancedthrough the nasal passage of a child and enter in to the larynx rest of theprocedure will be differed according to the study arm.

**Study arm 01: Nebulization group.**

No localinstillation of lignocaine through the bronchoscope will be done at larynx.However, while advancing the bronchoscope to larynx if child develop cough andif cough persisted more than 10 seconds, 1mg/kg lignocaine will be instilled tothe larynx through the bronchoscope (Already prepared 1:1 diluted solution willbe used). Similarly, while passing the scope through trachea and if childdevelop cough and if it is persisting for more than 10seconds another 1mg/kgalready prepared lignocaine solution will be instilled in to carina through thebronchoscope.

**Study arm 02 : Local instillation group**

Lignocaine2mg/kg willbe instilled to the larynx throughthe working channel of the bronchoscope for all children who have been randomlyallocated to study arm 02. Then thebronchoscope will be advanced through vocal cords. If child develop cough andif it is persisting for more than 10 seconds preventing the access through thevocal cords additional 1mg/kg lignocaine will be instilled to vocal cords. Thenall children of study arm 02 will received 2mg/kg of lignocaine to the carinathrough the bronchoscope in “as you go fashionâ€. If child develop cough duringthe examination of trachea and bronchi after this mandatory dose and if coughpersisting continuously more than 10seconds, an additional dose of already preparedlignocaine 1mg/kg will be given to lower airway.

Criteria foradditional doses-

For botharms, consideration for additional doses of topical lignocaine to be done ifchild’s cough persisting continuously for more than 10 seconds only.Intermittent cough during the procedure will not be consider as an indicationfor additional doses. All the topical anaesthesia used for the procedure willbe documented and total dose, including additional doses will not be exceed6mg/kg.

All the childrenwill be given free flow of 5l/min O2 throughout the procedure and O2flow will be increased if SpO2 drops <92% or >5% of thebaseline value for more than 10s.

The cumulativetime duration which child develop desaturations (SpO2 drop >5%from pre-procedure value) during and 1h after the procedure will be recorded inseconds, using another stop watch. The minimum SpO2 level whichchild develops will also be recorded.

Child minimalheart rate and maximum heart rate during and 1h after the procedure will berecorded to calculate the deviation from pre procedure value later.

Aftercompletion of the procedure child will be sent back to the paediatric ward orday care and SpO2 and Pulse rate will be monitored with a pulse oxymetercontinuously for 2h or  till child becomefully awake, whichever comes last.

**Assessment of the frequency of child’scough and intensity of child’s cough and stridor**

This will bedone later by watching the video of the child’s face during the procedure bytwo independent observers who are blinded for the mode of topical anaesthesia. Tenrecordings will be assess at a time. While, playing the video, two observerswill count the number of time child cough during the procedure. The twoobservers will do this independently and chart it while, unrevealing to eachother. The mean count of both observers will be taken and it will be divided bythe total duration of the procedure (already measured with a stopwatch) to getthe rate. After watching the video record the same observers will give anoverall rating for the intensity of child’s cough independently. For this 100mmvisual analogue scale will be used according to the ERS guidelines onassessment of cough (33). Same visual analogue scale will be used in samemanner to give an overall rate about stridor, if child developed or worsened itdue the procedure. Both observers will give these rating independentlyunrevealing to each other and average will be taken as the value for thatparticular child. Same room and same time of the day will be used to play therecordings.

Same level ofvolume and same audio and video settings will be kept for all assessments.

Same twoindividuals who are not participating for the study directly will do all theblinded assessments.

**Assessment of “Easiness of theprocedureâ€-Physicians and nurse’s view**

A rating foroverall easiness of the procedure will be given by the bronchoscopist andbronchoscopy nurse within 10min after completion of the procedure using a 100mmVAS.

**Assessment of Child’s overall perceptionof pain during the procedure**

Wong-BakerFACES® Pain Rating Scale **(http://www.wongbakerfaces.org/)**will be givento children >5y to rate their feeling of pain during the procedure(Annexure-05). The way of rating will be explained to children in simplelanguage. Assessment will be done 2h after the procedure or when they are fullyawake, whichever comes last. Even though, this scale has been validated for theassessment of pain in children above 3years, children over 5year will be takento obtain more accurate assessment.

**SAMPLE SIZE**

There is no published study which compared these two method of localanesthesia of airway for bronchoscopy in children. Therefore, 50 patientswillbe enrolled for the trail at the beginning. Then, an interim analysis will bedone after 30 patients to calculate sample size and study will be proceed toobtain that sample size.

**DATACOLLECTION**

Data will be collected using a pre-prepared data collection sheet by theprincipal investigator

This will include- Identification and demographic data, base line vitalsigns and outcome variable measures.

**STATISTICALANALYSIS**

Data will be analyzed according to the intention to treatprincipal.Add- Data will presented as median (IQR) if data notnormally distributed and will be compared using MannWhitney test. The mean frequency of cough(number of cough episodes per a minute) in two groups will be calculated andexpressed as mean+ SD. Statistical significance will be assessed usingstudent’s t test.  Score for intensity ofcough, stridor, assessment of easiness by the physician and nurse,  assessment of perceived pain by children>5yusing the pain score, total  doses ofmidazolam and lignocaine (expressed as mg/kg), total duration of the procedureand time taken to enter through vocal cords (expressed in seconds), minimumheart rate, maximum heart rate and deviation of heart rate from pre-procedurevalue, total duration of time which SpO2 drop >5% frompre-procedure value will also analyzed in a similar way. Chi-squared test willbe used for assess the number of children who develop stridor during theprocedure, number of children who develop bradycardia (heart rate <60/min)during the procedure.

**ETHICAL ISSUES:**

Children already selected for bronchoscopy due to a medical indicationwill be taken for the study. No new or additional drug will be used. Only theroute of administration of a routinely used drug will be changed. The safetyand effectiveness of the nebulized route for the administration of topicallignocaine has been proven in adults. Even a higher doses of nebulizedlignocaine has been used, the plasma levels proven to be well below the toxiclevel. (According to the studies in adult bronchoscopies and upper airwayprocedures in children other than flexible bronchoscopy). Nebulized lignocaineup to 8mg/kg for bronchoscopy has been proven to be safe in children. We use lignocaine4mg/kg for this study and go up to maximum 6mg/kg if it is needed only duringthe procedure. Children will be monitored closely during and after theprocedure. If a child develops any adverse effect it will be managedappropriately by a competent medical team at AIIMS. This trial will be conductedonly after obtaining the approval from AIIMS ethics committee.

**CostsInvolved**

Drugs will besupplied in the hospital. There will be no charges for the study procedures orparticipation

 **DSMB**

A committee ofthree persons not involved in the trial or data collection will be formed tosupervise the trial.

**Disseminationof Results**

The data will beanalysed and manuscript will be prepared by Dr S.S.C.de Silva  and he will be the lead author. Allsupervisors will be co-author for the manuscript.

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Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-10
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Children aged 1 month to 16y who are already selected for flexible bronchoscopy under conscious sedation due to a medical indication as decided by the in-charge professor of the unit to do at the paediatric bronchoscopy suite, AIIMS-Delhi.

Exclusion Criteria

• History of any kind of adverse reaction to lignocaine given by any route 2.
• History of any adverse reaction to any other medication which use in the procedure (Atropine, Midazolam, Fentanyl) 3.
• Children who are already given sedative drugs or lignocaine within 72hours of the procedure.
• Children who are already on ventilatory support via ETT or tracheostomy 5.
• Children with SpO2 <92% with 5l/min O2 at the time of enrolment 6.
• Children with GCS <15/15 at the time of enrolment, due to any reason 7.
• Already diagnosed children with cardiac arrhythmias 8.
• Not consented.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of the child’s cough during the procedure (Number of cough episodes per a minute)	Count the number of time child cough during the procedure by watching a video record of the procedure. It will be divided by total time of the procedure to get rate. | This will be done by two blinded observers who are not directly participate for the study in separate sessions of 10 participants videos at a time.
Outcome	Frequency of the child’s cough during the procedure (Number of cough episodes per a minute)
Measure	Count the number of time child cough during the procedure by watching a video record of the procedure. It will be divided by total time of the procedure to get rate.
Intensity of the cough	The blinded observers who count the frequency of cough will give a rating regarding the intensity of the cough using a 100mm VAS after watching the video recording.
Intensity of stridor which developed or worsened due to the procedure	Same observers who count the frequency of cough will also give a rating regarding the intensity of the stridor using a 100mm VAS after watching the video recording.
Desaturations during the procedure (SaO 2 drop >5% from Baseline)	Document SaO 2 before nebulization and continuous monitoring of SaO 2 during and up to 1 hour after procedure with a pulse oxymeter. Total duration of desaturation >5% from baseline is measured in seconds using a stop watch
Minimum O2 saturation detected during the procedure and the percentage drop from baseline.	Minimum SaO 2 during and 1h following   the procedure is documented and percentage drop from baseline value will be calculated
Haemodynamic stability-Maximum drop in pulse rate	Minimum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)
Haemodynamic stability Maximum rise in pulse rate	Maximum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)
Haemodynamic stability Maximum fluctuation of pulse rate	Difference between maximum and minimum pulse rate (Expressed as percentage deviation from baseline value)
Total dose of lignocaine used for the procedure	Cumulative dose of lignocaine used in the procedure . (Expressed as mg/kg)
Total dose of sedative medication (midazolam)used for the procedure	Total dose of midazolam including top ups during the procedure. (Expressed as mg/kg)
Older children’s overall perception of the maximum pain during the procedure.	Wong-Baker FACES® Pain Rating Scale will be given to children >5y to rate their feeling of pain during the procedure (2h after the procedure or when they are fully awake, whichever comes last)
Time taken to enter in to the lower airway through vocal cords	Time from insertion of the tip of the bronchoscope to a nostril to insertion of bronchoscope through the vocal cords. Directly measured with a stop watch. Expressed in seconds.
Total duration of the procedure	Time from insertion of the tip of the bronchoscope to a nostril to removal the tip of the bronchoscope from the nostril after fully completion of the procedure. Directly measured with another stop watch. Expressed in seconds
Bronchoscopist’s and bronchoscopy nurse’s overall feeling about the easiness of the procedure	Physician who did the bronchoscope and nursing sister who assisted for the procedure will give an overall rate about the easiness of the procedure using a 100mm VAS within 15min after completion of bronchoscopy.

Secondary Outcome Measures

Name	Time	Method
Intensity of the cough of the participant during the procedure	The blinded observers who count the frequency of cough will give a rating regarding the intensity of the cough using a 100mm VAS after watching the video recording.
Total dose of sedative medication (midazolam)used for the procedure	Total dose of midazolam including top ups during the procedure. (Expressed as mg/kg)
Total duration of the procedure	Time from insertion of the tip of the bronchoscope to a nostril to removal the tip of the bronchoscope from the nostril after fully completion of the procedure.
Intensity of stridor which developed or worsened due to the procedure	Same observers who count the frequency of cough will also give a rating regarding the intensity of the stridor using a 100mm Visual Analogue Scale after watching the video recording.
Desaturations during the procedure (SaO2 drop more than 5 percent from Baseline)	Document SaO2 before nebulization and continuous monitoring of SaO2 during and up to 1 hour after procedure with a pulse oxymeter. Total duration of desaturation more than 5 percent from baseline is measured in seconds using a stop watch
Minimum O2 saturation detected during the procedure and the percentage drop from baseline.	Minimum SaO2 during and 1h following the procedure is documented and percentage drop from baseline value will be calculated
Haemodynamic stability-Maximum drop in pulse rate	Minimum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)
Total dose of lignocaine used for the procedure	Cumulative dose of lignocaine used in the procedure. (Expressed as mg/kg)
Haemodynamic stability Maximum rise in pulse rate.	Maximum pulse rate during and 1h following the procedure will be noted while, continuously monitoring pulse rate with a pulseoxymeter. (Expressed as percentage deviation from baseline value)
Time taken to enter in to the lower airway through vocal cords	Time from insertion of the tip of the bronchoscope to a nostril to insertion of bronchoscope through the vocal cords. Directly measured with a stop watch. Expressed in seconds.
Haemodynamic stability Maximum fluctuation of pulse rate.	Difference between maximum and minimum pulse rate (Expressed as percentage deviation from baseline value)
Older children’s overall perception of the maximum pain during the procedure.	Wong-Baker FACES® Pain Rating Scale will be given to children more than 5y to rate their feeling of pain during the procedure (2h after the procedure or when they are fully awake, whichever comes last)
Bronchoscopist’s and bronchoscopy nurse’s overall feeling about the easiness of the procedure	Physician who did the bronchoscope and nursing sister who assisted for the procedure will give an overall rate about the easiness of the procedure using a 100mm VAS within 15min after completion of bronchoscopy.

Trial Locations

Locations (1)

All India Institute of Medical Sceiences, New Delhi; 🇮🇳 Delhi, DELHI, India

All India Institute of Medical Sceiences, New Delhi

🇮🇳Delhi, DELHI, India

SETHUGE SAJITH CHANNA DE SILVA

Principal investigator

9205624322

cdesilva50@yahoo.com