A clinical trial to study the effects of combinations of three drugs dexmedetomidine,ketamine and midazolam for intranasal premedication in paediatric patients.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2018/11/016471
- Lead Sponsor
- Aiims jodhpur
- Brief Summary
**COMPARISIONOF INTRANASAL DEXMEDETOMIDINE-MIDAZOLAM,DEXMEDETOMIDINE-KETAMINE ANDMIDAZOLAM-KETAMINE**
**FORPREMEDICATION IN PAEDIATRIC PATIENTS:**
**A DOUBLEBLINDED RANDOMIZEDTRIAL.**
Dissertationsubmitted to
AllIndia Institute of Medical Sciences
Jodhpur
Inpartial fulfillment of requirement for the degree of**MD** in Anaesthesiology and Critical Care.
Session:January 2018-2021
**Candidate**:
**Dr.Vaishnavi B.D.**
Junior Resident
**Guide:**
**Dr.ShilpaGoyal**
Associate professor
**Co-guide**: **Co-guide**:
**Dr. Pradeep Bhatia Dr.Ankur Sharma**
Professor and Head Assistantprofessor
**Co-guide**: **Co-guide**:
**Dr. Priyanka Sethi Dr. NarenderKaloria**
Assistant professor Assistant professor
**Departmentof Anaesthesiology and Critical Care**
**All India Institute of Medical Sciences, Jodhpur**
**Table of content**
· Synopsis
· Introduction
· Reviewof Literature
· Aimsand Objectives
· Materialand Methods
· StatisticalAnalysis
· EthicalConsideration
· Bibliography
· Appendix
**SYNOPSIS**
Premedicationplays an important role in paediatricanaesthesia as it is helpful in decreasingchild’s stress and anxiety thus facilitating smooth induction of anaesthesia.Atleast60% of children experience pre-operative anxiety which can produce aggressivereaction, increased distress in children and parents, may prolong induction ofanaesthesia, greater requirement of analgesics, emergence agitation, post-operativepsychological and behavioral issue[1].
Pre-operativeanxiety and its effects inintra-operative and post-operative period can beprevented by effective premedication in an acceptable and non –traumatic routeinorder to avoid extra stress to the child. It is a double blinded randomized trial,intended to compare the level of separation anxiety from parents by using combinationof three different drugs for pre-medication through intranasal route inpediatric agegroup(2-4 years) undergoing surgery under general anesthesia.
**INTRODUCTION**
Premedicationin paediatricanaesthesia aims at relieving preoperative and postoperativeanxiety, facilitating good parental separation and smooth induction of anaesthesia.Anxiety and fear in children lead to increased levels of catecholamines in thebody, thereby leading to tachycardia, hypertension, tachypnea[2].There is also difficulty in intravenous (IV) access, separation from parentsand induction of anaesthesia. It can also lower the pain threshold leading tooffensive behaviour. Psychological stress because of forced separation cancause nightmares and post-operative behavioral abnormality. Premedicationfacilitates in overcoming these difficulties. So the route of administration ofpremedication shouldbe acceptable to the child and non-traumatic. Severalstudies have been tried to find the best sedative agent and best route ofadministration. Most commonly used method is IV drug administration. Since IVcannulation is painful; it could lead to long term psychological problem in thechild such as refusing contact with health care provider[3].Therefore other routes of premedication have been tried like oral, intranasal,nebulization,sublingual , rectal which are non- traumatic. Intranasalpremedication has advantage over others as it requires no venous puncture, richvascularization,good drug permeability and bypasses first pass hepatic metabolism.Hence, it leadsto rapid absorption into systemic circulation and ensuingeffective and rapid sedationof children[4,5]. Intranasal route mayhave some minor side effects like burning, stinging or irritation inside nose,crusting, running nose, watery eyes, coughing or sneezing. Children have beenfound to have high acceptability to intranasal route of premedication administrationin previous studies .[5,6,7]
Midazolamand ketamine are most commonly used for premedication in children. Midazolam isa water soluble benzodiazepine known to have a rapid onset and short durationof action but has no analgesic effect and causes respiratory depression.Ketamine produces dissociativeanesthesia that creates a trance like state withproperties of sedation ,amnesia and analgesia. Dexmedetomidine is an alpha 2-adreno-receptor agonist has an analgesic and sedative action with norespiratory depression. These three drugs have been compared individually or incombination with individual drug but never thesethree combinations have beencompared with each other. Our study aims at assessing the combination of thesethree premedication drugs in preventing preoperative anxiety in paediatric agegroup(2-4years) and thus preventing the ill effects of anxiety.
**Review of Literature**
**Mostafa et al[8],**in 2012 published a study comparing premedication with intranasal dexmedetomidine(1mg/kg),midazolam(0.2mg/kg) and ketamine(5mg/kg) in 96 children of age 2-8 yearsundergoing bone marrow biopsy and aspirate. They concluded that dexmedetomidinegroup achieved a faster sedation score at a point of 10 minutes, then all groupsachieved a comparable sedation score at a point of 25 minutes, bothdexmedetomidine and midazolam group had better sedation score than ketaminegroup at 30 minutes. Children achieved child-separation score grade 1 wassignificantly higher in dexmedetomidine group than in midazolam and ketaminegroups.
**Gyanesh et al**[5]in2014 published a study in 150 children of age 1-10years undergoing MRI,comparing intranasal dexmedetomidine and intranasal ketamine as premedication.They concluded that dexmedetomidine and ketamine were equally effective byintranasal route.
**Sheta et al[9]** in 2014published a study in 72 children aged 1-3 years undergoing complete dentalrehabilitation, comparing intranasal dexmedetomidine and intranasal midazolam.They found that intranasal dexmedetomidine(1mg/kg)is safe and effective alternative for premedication in children, it resulted insuperior sedation in comparison to intranasal midazolam (0.2mg/kg).
**Khatavkar et al[6]**in 2014 published a study comparing intranasal midazolam (0.15mg/kg) withketamine(1mg/kg) and intranasal midazolam(0.2mg/kg) in 60 children aged 1-12years .They concluded that intranasal premedication allows rapid andpredictable sedation in children. Both the groups provide good level ofsedation but quality of sedation, analgesia,and comfort is significantly betterin midazolam with ketamine group.
**Wang et al [10]**in 2014published a study comparing two doses of dexmedetomidine (1mg/kgand 2mg/kgintranasally)effects on sedation, attenuation of cardiovascular and arousal response duringanesthesia induction and intubation in pediatric patients. They concluded thatintranasal dexmedetomidine (2mg/kg)administered 30 minutes before induction of anesthesia, provides considerableeffect to attenuate the increasing MAP caused by intubation response, produceoptimal sedation, more favorable anesthesia induction course in pediatricpatients. Premedication of intranasal dexmedetomidine is a considerable way toblunt cardiovascular and arousal response to endotracheal intubation.
**Narendra et al[11],** in2015 published a study comparing intranasal ketamine(5mg/kg) and intranasalmidazolam(0.2mg/kg) in 50 children aged 1 to 10years. They concluded that bothmidazolam and ketamine are an effective pediatric premedication throughintranasal route, midazolam has an early onset of sedation and is associatedwith fewer side effects.
**Jia et al**[12]in2017 published a study in which total of 135 children aged 2-5 years scheduledfor eye surgery were randomly allocated to receive intranasal dexmedetomidine2.5mg/kg (group D) ,oral ketamine 3mg/kg andintranasal dexmedetomedine 2mg/kg(group DK) or oral ketamine 6mg/kg (group K) 30 mins before surgery. They cameto a conclusion that intranasal dexmedetomidine and oral ketamine produce satisfactoryparent separation and more successful venous cannulation, allowing children tosmoothly accept induction of general anesthesia.
**Bhat , Santhosh , Annigeri et al[13]**in 2018 published a study in which 54 children aged 1-6 years scheduled forelective minor surgery were allocated to receive intranasal dexmedetomidine 1mg/kgand another group received dexmedetomidine 1mg/kgand ketamine 2mg/kg intranasally. They concluded that dexmedetomedine aspremedicant in children provide acceptable parenteral separation and decreasesemergence agitation , however mask acceptance in operating room is poor.Combination of dexmedetomidine and ketamine does not increase the success of premedication.
**Gharde et al[14],**published study in 2018 in 60 childrenaged 1-10 years evaluating the efficacyof intransal midazolam (0.2mg/kg ),ketamine (10mg/kg) and their mixture ofpremedication ( midazolam – 0.1mg/kg , ketamine- 7.5mg/kg ) in children withtetralogy of fallot undergoing intracardiac repair. They concluded thatintranasal ketamine is an effective method of premedication than intranasalmidazolam and the combination of two provides no benefit as compared toketamine alone, but is better than midazolam alone.
**Kumar et al [15],** in2018 published a study in 60 children aged 2-12years comparing efficacy ofintranasal dexmedetomidine (1mg/kg) vsoral midazolam (0.5mg/kg), they concluded that intransaldexmedetomidine produced a superior sedation score atseparation and induction but normal behavior scores in comparision to oral midazolam in pediatric patients.
**Gupta et al[2],** in2018 published a study in 60 children aged 1-8 years scheduled for electivebrain MRI , randomly assigned to the intranasal dexmedetomidine ( 1mg/kg) or intranasal midazolam (0.2mg/kg). Theyfound that intranasal dexmedetomidine results in more successful parentalseparation and yields a higher sedation level at a time of induction ofanesthesia than intranasal midazolam as premedication, with negligible side effects,however its onset ofaction is relatively prolonged.
**Justification of the study:**
Hence, literaturessuggest that intranasal route is potential alternative and effective route ofpremedication for paediatric patients. Many studies have been done comparingthe intranasal pre-medication drugs individually or an individual premedicationdrug is compared with combination of premedication drugs using certain scales toassess sedation and parental separation. Many studies have shown thatcombination of premedication drugs have superior effect than individual drug[6,15].Asthere has been no single study comparing the three different combination ofintranasally administered drugs as a premedication that is why the presentstudy will be done.
**AIMS AND OBJECTIVES**
**AIM:**
To compare three different combinations of intranasallyadministered drugs for premedication in children undergoing surgeries undergeneral anesthesia.
**OBJECTIVES**:
PRIMARY:To assess anxiety level at separation from the parents after 30 minutes ofadministration of intranasal premedication.
SECONDARY:To assess the level of sedation , easeof iv cannulation , mask acceptance after 30 minutes of administration ofintranasal premedication.
**MATERIAL AND METHODS**:
**STUDY SETTING**:
Patientsincluded in the study group will be intervened in the preoperative period tillmask acceptance in the Department of Anesthesiology and Critical Care, AIIMS,Jodhpur.
**STUDY DESIGN**:
ADouble Blinded,Randomized trial
**STUDY PARTICIPANTS:**
**INCLUSION CRITERIA**:
Paediatric patients of age 2-4 yearsbelonging toASA 1 posted for elective surgeries under general anaesthesia.
**EXCLUSION CRITERIA**:
1.Parentrefusal.
2.Patients with recent history and active nasal bleeding.
3.Patients with nasal mass.
4.Patients with active URI.
5.Patients with history of pyschiatric illness.
6.Patients with cardiac arrhythmia and congenital heart disease.
7.Patients with raised ICT and raised IOP.
8.Patients with history of allergy to drugs been used.
9.Childrenwho fail to achieve parental separation even after 30 minutes of pre-medication.
**Sampling and Sample size:**
Thestudy will be done on 150 patients considering anxiolysis(Calm at separation) as 30% in midazolam group and63.3% in midazolam + ketamine group (Khatavkar SS 2014)[7], we estimatea sample size of 49 per group at 98.3% confidence interval(after applyingBonferroni correction to 95% confidence interval for three group comparision),70% power and 10% contingency.
Thepatients will be randomly divided into three groups of 50 each and will beallocated to the group by computer random number table method as follows.
1**. Group A(DM**): Patients pre-medicatedwith 1µg/kg dexmedetomidine and 0.15mg/kg midazolam intranasally.
2**. Group B(DK)**: Patients pre-medicatedwith 1µg/kg dexmedetomidine and 2mg/kg ketamine intranasally.
3. **Group C (MK**):Patients pre-medicated with 0.15mg/kg midazolam and 2mg/kg ketamineintranasally.
**METHODOLOGY**
Pre-anestheticcheck-up will be done for these patients prior to surgery.Patients will be keptfasting as per the standard protocol.The procedure of premedication will beexplained to the patient’s attendant.Informed written consent will be takenfrom parents or nearest kin.
**Pre-sedation behavior** isassessed on 4 point scale(1=calm, cooperative, 2=anxious but reassurable,3=anxious but not reassurable , 4= crying or resisting).
All studydrugs will be prepared by an independent investigator not involved in theobservation or administration of anaesthesia. Each drug will be administered byan observer completely blind to the study and to the group allocation of thechild. This observer will also recordthe pre-sedation scores. The attending anaesthesiologistswill be blinded to thestudy drug and the master codes and will collect rest of data.
Inall the groups, the drug will be given 30 mins before surgery using 1mltuberculin syringe and the drug will be deposited in both the nostrils equally with child in recumbent position.Salinewill be added to make the total volume to 1 ml.
Thesigns of nasal irritation (stingy and scratchy nose, watering of nose and eyes)will be observed.
Continuousmonitoring of heart rate and SpO2 and mean arterial pressure will bedone in pre-operative period and will be recorded every 5 minutes for 30 minutes.
At30 minutes after intranasal dose, sedation,ease of separation from parents andiv cannulation will be evaluated by using following scores.
**Parent** –**separation anxiety scale:**
· Patientunafraid,cooperative ,asleep=1
· Slightfear or crying, quiet with reassurance =2
· Moderatefear,crying not quiet with reassurance =3
· Cryingneed for restraint =4
**Sedation score**:
· Agitated= 4
· Awake=3
· Drowsy=2
· Asleep=1
**Ease of ivcannulation**:
· Noreaction =1
· Minorresistance= 2
· Fightswithout success = 3
· Fightswith success = 4
Maskacceptance with 100% O2 for pre-oxygenation on OT table will also beassessed as per the following score.
**MAS (Mask acceptance scale)**:
· Unafraid,cooperative ,accepts mask readily= 1
· Slightfear of mask , easily reassured = 2
· Moderatefear of mask,not calmed with reassurance =3
· Terrified, crying and combative = 4
**Statistical analysis plan:**
Data will be enteredand analysed using SPSS IBM software version 22 (IBM SPSS Advanced statistics,Chicago, IL, USA)
Nominal data will bedescribed using frequency and percentages and compared using chi square test orFischer Exact test.
Ordinal Data will bedescribed using Median and Interquartile Range (IQR) and compared usingMann-Whiteney U test.
Continuous data willbe described using mean +/- SD and compared using unpaired t test.
P value of <0.05will be considered as statistically significant.
**ETHICAL CONSIDERATIONS**
- The study is ethical as all the three combination of premedication and the route of administration of premedication have been used in the previous studies are standard and safe.
- Informed written consent will be taken from patient’s attendant in English/Hindi language.
- They will be given full information about the study & the procedure they are undergoing.
- Strict confidentiality about the patient information will be maintained
**BIBLIOGRAPHY**
1. Litke J, Pikulska A, Wegner T. Management of perioperative stress inchildren and parents. Part I – The preoperative period. Anaesthesiol IntensiveTher.2012;44:165â€9.
2. [Gupta A](https://www.ncbi.nlm.nih.gov/pubmed/?term=Gupta%20A%5BAuthor%5D&cauthor=true&cauthor_uid=28781452), [Dalvi NP](https://www.ncbi.nlm.nih.gov/pubmed/?term=Dalvi%20NP%5BAuthor%5D&cauthor=true&cauthor_uid=28781452), [Tendolkar BA](https://www.ncbi.nlm.nih.gov/pubmed/?term=Tendolkar%20BA%5BAuthor%5D&cauthor=true&cauthor_uid=28781452). Comparisonbetween intranasal dexmedetomidine and intranasal midazolamas premedication for brain magnetic resonance imaging inpediatricpatientA prospective randomized double blind trial.[J AnaesthesiolClinPharmacol.](https://www.ncbi.nlm.nih.gov/pubmed/28781452 "Journal of anaesthesiology, clinical pharmacology.") 2017;33:236-240.
3. Watson AT, Visram A. Children’s preoperative anxiety and postoperativebehaviour. PaediatrAnaesth 2003; 13: 188-204.

4. Abrams R, Morrison JE, Villasenor A, Hencmann D, Da Fonseca M, MuellerW. Safety and effectiveness of intranasal administration of sedativemedications (ketamine, midazolam, or sufentanil) for urgent brief pediatricdental procedures. AnesthProg 1993; 40: 63-6.
5. [Gyanesh P](https://www.ncbi.nlm.nih.gov/pubmed/?term=Gyanesh%20P%5BAuthor%5D&cauthor=true&cauthor_uid=23800984), [Haldar R](https://www.ncbi.nlm.nih.gov/pubmed/?term=Haldar%20R%5BAuthor%5D&cauthor=true&cauthor_uid=23800984), [Srivastava D](https://www.ncbi.nlm.nih.gov/pubmed/?term=Srivastava%20D%5BAuthor%5D&cauthor=true&cauthor_uid=23800984), [Agrawal PM](https://www.ncbi.nlm.nih.gov/pubmed/?term=Agrawal%20PM%5BAuthor%5D&cauthor=true&cauthor_uid=23800984), [Tiwari AK](https://www.ncbi.nlm.nih.gov/pubmed/?term=Tiwari%20AK%5BAuthor%5D&cauthor=true&cauthor_uid=23800984), [Singh PK](https://www.ncbi.nlm.nih.gov/pubmed/?term=Singh%20PK%5BAuthor%5D&cauthor=true&cauthor_uid=23800984).Comparison between intranasal dexmedetomidine and intranasal ketamine as premedication for procedural sedation in children undergoing MRI:a doubleblind, randomized, placebo-controlled trial.[J Anesth.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Comparison+between+intranasal+dexmedetomidine+and+intranasal+ketamine+as+premedication+for+procedural+sedation+in+children+undergoing+MRI%3A+A+double%E2%80%90blind%2C+randomized%2C+placebo%E2%80%90controlled+trial "Journal of anesthesia.") 2014;28:12-8.
6. [Khatavkar SS](https://www.ncbi.nlm.nih.gov/pubmed/?term=Khatavkar%20SS%5BAuthor%5D&cauthor=true&cauthor_uid=24665234), [Bakhshi RG](https://www.ncbi.nlm.nih.gov/pubmed/?term=Bakhshi%20RG%5BAuthor%5D&cauthor=true&cauthor_uid=24665234) . Comparison of nasal Midazolam with Ketamine versus nasal Midazolam asa premedication in children. [Saudi J Anaesth.](https://www.ncbi.nlm.nih.gov/pubmed/24665234 "Saudi journal of anaesthesia.") 2014 ;8:17-21.
7. [Bhat R](https://www.ncbi.nlm.nih.gov/pubmed/?term=Bhat%20R%5BAuthor%5D&cauthor=true&cauthor_uid=27212773), [Santhosh MC](https://www.ncbi.nlm.nih.gov/pubmed/?term=Santhosh%20MC%5BAuthor%5D&cauthor=true&cauthor_uid=27212773), [Annigeri VM](https://www.ncbi.nlm.nih.gov/pubmed/?term=Annigeri%20VM%5BAuthor%5D&cauthor=true&cauthor_uid=27212773), [Rao RP](https://www.ncbi.nlm.nih.gov/pubmed/?term=Rao%20RP%5BAuthor%5D&cauthor=true&cauthor_uid=27212773)
Comparison of intranasal dexmedetomidine and dexmedetomidine-ketamine for premedication in pediatrics patients: A randomized double-blind study. [Anesth Essays Res.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Comparison+of+intranasal+dexmedetomidine+and+dexmedetomidine-+ketamine+for+premedication+in+pediatrics+patients%3A+A+randomized+double-blind+study+.+Anesth+Essays+Res "Anesthesia, essays and researches.") 2016;10:349-55.
8. Mostafa MG, MorsyKM.Premedication with intranasal dexmedetomidine,midazolam and ketamine for children undergoing bone marrow biopsy and aspirate.EgyptianJournal Of Anaesthesia 2013;29:131-5.
9. [Sheta SA](https://www.ncbi.nlm.nih.gov/pubmed/?term=Sheta%20SA%5BAuthor%5D&cauthor=true&cauthor_uid=24237879), [Al-Sarheed MA](https://www.ncbi.nlm.nih.gov/pubmed/?term=Al-Sarheed%20MA%5BAuthor%5D&cauthor=true&cauthor_uid=24237879), [AbdelhalimAA](https://www.ncbi.nlm.nih.gov/pubmed/?term=Abdelhalim%20AA%5BAuthor%5D&cauthor=true&cauthor_uid=24237879). Intranasal dexmedetomidine vs midazolam for premedication in childrenundergoing complete dental rehabilitation:a double-blinded randomizedcontrolled trial.[PaediatrAnaesth.](https://www.ncbi.nlm.nih.gov/pubmed/?term=Intranasal+dexmedetomidine+%E2%80%A8vs+midazolam+for+premedication+in+children+undergoing+complete+dental+rehabilitation%3A+A+double%E2%80%90blinded+randomized+controlled+trial "Paediatric anaesthesia.") 2014 Feb;24:181-9.
10. [Wang SS](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wang%20SS%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Zhang MZ](https://www.ncbi.nlm.nih.gov/pubmed/?term=Zhang%20MZ%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Sun Y](https://www.ncbi.nlm.nih.gov/pubmed/?term=Sun%20Y%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Wu C](https://www.ncbi.nlm.nih.gov/pubmed/?term=Wu%20C%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Xu WY](https://www.ncbi.nlm.nih.gov/pubmed/?term=Xu%20WY%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Bai J](https://www.ncbi.nlm.nih.gov/pubmed/?term=Bai%20J%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Cai MH](https://www.ncbi.nlm.nih.gov/pubmed/?term=Cai%20MH%5BAuthor%5D&cauthor=true&cauthor_uid=24224515), [Lin L](https://www.ncbi.nlm.nih.gov/pubmed/?term=Lin%20L%5BAuthor%5D&cauthor=true&cauthor_uid=24224515). The sedative effects andthe attenuation of cardiovascular and arousal responsesduring anesthesia induction and intubation in pediatric patients:a randomizedcomparison between two different doses of preoperative intranasaldexmedetomidine.[PaediatrAnaesth.](https://www.ncbi.nlm.nih.gov/pubmed/?term=The+sedative+effects+and+the+attenuation+of+cardiovascular+and+arousal+responses+during+anesthesia+induction+and+intubation+in+pediatric+patients%3A+a+randomized+comparison+between+two+different+doses+of+preoperative+intranasal+dexmedetomidine "Paediatric anaesthesia.") 2014;24:275-81.
11. Narendra PL, Naphade RW, Nallamilli S, Mohd S. A comparison ofintranasal ketamine and intranasal midazolam for pediatric premedication.Anesth Essays Res 2015;9:213-8.
12. [Jia JE](https://www.ncbi.nlm.nih.gov/pubmed/?term=Jia%20JE%5BAuthor%5D&cauthor=true&cauthor_uid=23848405), [Chen JY](https://www.ncbi.nlm.nih.gov/pubmed/?term=Chen%20JY%5BAuthor%5D&cauthor=true&cauthor_uid=23848405), [Hu X](https://www.ncbi.nlm.nih.gov/pubmed/?term=Hu%20X%5BAuthor%5D&cauthor=true&cauthor_uid=23848405), [Li. WX](https://www.ncbi.nlm.nih.gov/pubmed/?term=Li%20WX%5BAuthor%5D&cauthor=true&cauthor_uid=23848405)A randomised study of intranasal dexmedetomidine and oral ketamine for premedication in children. [Anaesthesia.](https://www.ncbi.nlm.nih.gov/pubmed/?term=A+randomised+study+of+intranasal+dexmedetomidine+and+oral+ketamine+for+premedication+in+children "Anaesthesia.") 2013;68:944-9.
13. [Gharde P](https://www.ncbi.nlm.nih.gov/pubmed/?term=Gharde%20P%5BAuthor%5D&cauthor=true&cauthor_uid=17699904), [Chauhan S](https://www.ncbi.nlm.nih.gov/pubmed/?term=Chauhan%20S%5BAuthor%5D&cauthor=true&cauthor_uid=17699904), [Kiran U](https://www.ncbi.nlm.nih.gov/pubmed/?term=Kiran%20U%5BAuthor%5D&cauthor=true&cauthor_uid=17699904). Evaluation of efficacy of intranasal midazolam, ketamine andtheir mixture as premedication and its relation with bispectral index in children with tetralogy of fallot undergoing intracardiac repair.[Ann CardAnaesth.](https://www.ncbi.nlm.nih.gov/pubmed/?term=.Evaluation+of+Efficacy+of+Intranasal+Midazolam%2C+Ketamine+and+Their+Mixture+as+Premedication+and+its+Relation+with+Bispectral+Index+in+Children+with+Tetralogy+of+Fallot+Undergoing+Intracardiac+Repair "Annals of cardiac anaesthesia.") 2006;9:25-30.
14. Kumar L, Kumar A, Panikkaveetil R, Vasu BK, Rajan S, Nair SG. Efcacy ofintranasal dexmedetomidine versus oral midazolam for paediatric premedication.Indian J Anaesth2017;61:125-130.
15. Zanaty OM, El Metainy SA. A comparative evaluation of nebulizeddexmedetomidine, nebulized ketamine, and their combination as premedication foroutpatient pediatric dental surgery. AnesthAnalg 2015;121:167â€71.
***Appendix -1***
**All IndiaInstitute of Medical Sciences**
**Jodhpur,Rajasthan**
**InformedConsent Form**
Titleof Dissertation :COMPARISION OF INTRANASAL DEXMEDETOMIDINE-MIDAZOLAM, DEXMEDETOMIDINE-KETAMINEAND MIDAZOLAM-KETAMINE FOR PREMEDICATION IN PAEDIATRIC PATIENTS : A DOUBLEBLINDED RANDOMIZED TRIAL.
Nameof PG Student :Dr.Vaishnavi B.D.
Telephoneno:9620810873
Patient/VolunteerIdentification No. : \_\_\_\_\_\_\_\_\_\_\_\_\_\_
I,\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ F/oor M/o \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
R/o\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
givemy full, free, voluntary consent for my child to be a part of the study “COMPARISION OF INTRANASAL DEXMEDETOMIDINE-MIDAZOLAM,DEXMEDETOMIDINE-KETAMINE AND MIDAZOLAM-KETAMINE FOR PREMEDICATION IN PAEDIATRICPATIENTS : A DOUBLE BLINDED RANDOMIZED TRIAL.â€the procedure and nature ofwhich has been explained to me in my own language to my full satisfaction. Iconfirm that I have had the opportunity to ask questions.
Iunderstand that my child’s participation is voluntary and I am aware of myright to opt out of the study at any time without giving any reason.
Iunderstand that the information collected about my child and any of my child’s medicalrecords may be looked at by responsible individual from AIIMS Jodhpur or fromregulatory authorities. I give permission for these individuals to have accessto my child’s records.
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Place: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature/Left thumbimpression
Thisto certify that the above consent has been obtained in my presence.
Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Place: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Signature of PG Student
1. Witness1 2.Witness 2
Signature Signature
Name:\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Name:\_\_\_\_\_\_\_\_
Address: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Address: \_\_\_\_\_\_\_\_
***Appendix -2***
**AllIndia Institute of Medical Sciences**
**Jodhpur,Rajasthan**
***Participantinformation sheet***
Title of study:COMPARISION OF INTRANASAL DEXMEDETOMIDINE-MIDAZOLAM,DEXMEDETOMIDINE-KETAMINE AND MIDAZOLAM-KETAMINE FOR PREMEDICATION IN PAEDIATRICPATIENTS : A DOUBLE BLINDED RANDOMIZED TRIAL.
Name of the principal investigator :Dr.VaishnaviB.D.
PG Anaesthesiology & Critical Care
AIIMS Jodhpur
9620810873
I have been explained in my own understanding language by thePrincipal Investigator that they are doing this study “Comparision of intranasal dexmedetomidine-midazolam,dexmedetomidine-ketamine and midazolam-ketamine for premedication inpaediatricpatients : a double blinded randomized trial “ and the risk andbenefits associated with it.
I have been informed that I canwithdraw my child from the study at any time.
The data obtained from my child willbe used for the purpose of the study only. All my child’s records will be keptconfidential .
Patient name and Registration ID :
Signature of the parent/guardian :
***Appendix -3***
**Presedationbehaviour** is assessed on 4 point scale
| | |
| --- | --- |
|**Behaviour**
**SCORE**
|Calm, cooperative
1
|Anxious but reassurable
2
|Anxious but not reassurable
3
|Crying and resisting
4
***Appendix -4***
**Parent** –**separation anxietyscale :**
| | |
| --- | --- |
|**Parent separation anxiety**
Score
|Patient unafraid ,cooperative ,asleep
1
|Slight fear or crying , quiet with reassurance
2
|Moderate fear ,crying not quiet with reassurance
3
|Crying need for restraint
4
***Appendix -5***
**Sedation score** :
| | |
| --- | --- |
|**Level of sedation**
**Score**
|Agitated
4
|Awake
3
|Drowsy
2
|Asleep
1
***Appendix -6***
**Ease of iv cannulation**:
| | |
| --- | --- |
|**Cannulation**
**Score**
|No reaction
1
|Minor resistance
2
|Fights without success
3
|Fights with success
4
***Appendix -7***
**MAS ( mask acceptance scale )**:
| | |
| --- | --- |
|**Mask acceptance**
**Score**
|Unafraid , cooperative ,accepts mask readily
1
|Slight fear of mask, easily reassured
2
|Moderate far of mask,not calmed with reassurance
3
|Terrified , crying and combative
4
***Appendix -8***
**PROFORMA**
S.No. Date:
ThesisTitle :COMPARISIONOF INTRANASAL DEXMEDETOMIDINE-MIDAZOLAM, DEXMEDETOMIDINE-KETAMINE ANDMIDAZOLAM-KETAMINE FOR PREMEDICATION IN PAEDIATRIC PATIENTS: A DOUBLE BLINDEDRANDOMIZED TRIAL
IPD Serial no/Sticker:
**Presedation behaviorscale**:
| | |
| --- | --- |
|**Behavior**
**Score**
|Calm, cooperative
1
|Anxious but reassurable
2
|Anxious but not reassurable
3
|Crying and resisting
4
Any side effects ofintranasal administration : (yes / no )
| | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
|**Vitals**
0 mins
5 mins
10 mins
15 mins
20 mins
25 mins
30 mins
|SpO2
|HR
|Mean BP
**ScoresAt 30 minutes :**
| | |
| --- | --- |
| **Score**
|Sedation score
|Parent child separation score
|Ease of iv cannulation
|Mask acceptance scale
**Sedation score**:
| | |
| --- | --- |
|**Level of sedation**
**Score**
|Agitated
4
|Awake
3
|Drowsy
2
|Asleep
1
**Parent** –**separation anxiety scale :**
| | |
| --- | --- |
|**Separation anxiety**
**Score**
|Patient unafraid ,cooperative ,asleep
1
|Slight fear or crying , quiet with reassurance
2
|Moderate fear ,crying not quiet with reassurance
3
|Crying need for restraint
4
**Ease of iv cannulation**:
| | |
| --- | --- |
|**Cannulation**
**Score**
|No reaction
1
|Minor resistance
2
|Fights without success
3
|Fights with success
4
**MAS ( Mask acceptance scale )**:
| | |
| --- | --- |
|**Mask acceptance**
**Score**
|Unafraid , cooperative ,accepts mask readily
1
|Slight fear of mask, easily reassured
2
|Moderate far of mask,not calmed with reassurance
3
|Terrified , crying and combative
4
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 150
Paediatric patients of age 2-4 years belonging to ASA 1 posted for elective surgeries under general anaesthesia.
1.Parent refusal 2.Recent history and active bleeding 3.Patient with nasal mass 4.Patient with active URI 5.Patient with history of psychiatric illness 6.Patient with cardiac arrythmia and congential heart disease 7.Patient with raised ICT and raised IOP 8.Patient with history of allergy to drugs been used 9.Children who fail to achieve parental separation even after 30 minutes of premedication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the anxiety level at separation from parents At 30 minutes of intranasal premedication in paediatric patients.
- Secondary Outcome Measures
Name Time Method To assess the level of sedation, ease of iv cannulation ,mask acceptance At 30 minutes of intranasal premedication in paediatric patients.
Trial Locations
- Locations (1)
AIIMS JODHPUR
🇮🇳Jodhpur, RAJASTHAN, India
AIIMS JODHPUR🇮🇳Jodhpur, RAJASTHAN, IndiaDr Shilpa GoyalPrincipal investigator8003996880drshilpagoyal@yahoo.com