comparison of 2 routes of dexmedetomidine for pain relief in children undergoing infraumbilical surgeries
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2022/09/045492
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
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|**Methodology:** Patients fulfilling the inclusion criteria will be confirmed by anaesthesiologist during pre-anaesthetic check-up. Patients will then be assigned to two groups by sequentially numbered opaque sealed envelope technique (SNOSE)**Group C:** Caudal block with 0.2% Ropivacaine with 1 μg/kg dexmedetomidine (total vol. 1ml/kg) + intranasal saline (volume similar to intranasal dexmedetomidine) **Group N:** Caudal block with 0.2% Ropivacaine (1ml/kg) + intranasal instillation of dexmedetomidine (1μg /kg).According to the groups allocated intranasal and caudal drugs containing equal volumes of drug or normal saline will be loaded by the anaesthesiologist in the operating room.The primary investigator (blinded to the identity of the drug) will administer the preloaded drugs caudally and intranasally and monitor the patients intraoperatively and postoperatively.All patients will be kept fasting as per the institutional protocol.On arrival of patient in the operating room, standard ASA monitoring will be employed and baseline parameters including heart rate (HR), blood pressure (BP) and oxygen saturation (SpO2) will be recorded. Patients who do not have a preoperative intravenous access will be induced with 5 to 8 % sevoflurane followed by fentanyl (2mcg/ kg). Patients with intravenous access, will be induced with fentanyl (2mcg/ kg), propofol (2-3mg/kg). Airway will be secured using an appropriate sized laryngeal mask airway (LMA) after injecting IV Atracurium (0.5mg/kg).In accordance with the group allocation, in lateral decubitus position**Group N** will receive Caudal block with 0.2% Ropivacaine (1ml/kg)**Group C** will receive Caudal block with 0.2% Ropivacaine with 1 μg/kg dexmedetomidine (total volume 1ml/kg) .Patients will then be made supine. In accordance with the group allocation,**Group N** will receive intranasal dexmedetomidine (1 μg/kg); undiluted parenteralpreparation (100 μg/ml), instilled into both nostrils drop by drop in equal volume using a 1 mlsyringe in supine head down position.**Group C** will receive an equivalent volume of normal saline intranasally.Anesthesia will be maintained with isoflurane in oxygen : air mixture. Surgical intervention will be started atleast 10 minutes after the caudal injection/intranasal instillation.The HR , mean arterial pressure (MAP) and SPO2 will be recorded after induction, after LMA insertion, after caudal block and then every 10 min till the end of surgery. Hypotension will be defined as any episode of decrease of blood pressure (BP) by ≥20% from the baseline, treated with intravenous fluid bolus, ephedrine as necessary.Bradycardia will be defined as any episode of decrease of HR by ≥20% from the baseline. If HR is persistently <60/min; atropine 10-20mcg/kg will be administered.Any episode of hypotension or bradycardia will be recorded.If there is an increase in HR or MAP >20% then Inj. Fentanyl 0.5 mcg/kg will be injected intravenously and repeated if needed after 10 min and noted. Inj. ondansetron 0.1mg/kg administered 10 min before the end of surgery.On completion of surgery, after return of spontaneous ventilatory efforts, muscle relaxation will be reversed with {neostigmine (50 mcg/kg) and glycopyrrolate (20 mcg/kg )}and LMA will be removed on fulfilling the extubation criteria. Patients will be assessed on OR table for pain (FLACC score), sedation (4-point objective score) & post-operative agitation (WATCHA score).Patients will then be taken to the postanesthesia care unit (PACU).POST OPERATIVE EVALUATIONAll patients will be monitored in postanesthesia care unit for 6 h by the sister in-charge and the anaesthesia resident blinded to the patients’ group allocation. Supplemental oxygen will be given via facemask for 30 mins to all patients.Patients’ HR and oxygen saturation will be monitored continuously and the BP and respiratory rate will be recorded at 20 minute intervals. Any episode of hypotension, bradycardia or desaturation will be recorded. Postoperative respiratory depression will be defined as a decrease in SpO2 <95% on room air, requiring supplementary oxygen.The sedation will be assessed using 4-point objective score based on eye opening. Sedation will be assessed every 30 min for 2 h and then at 1 h intervals till 6 h. Time for recovery will be recorded as the period from discontinuation of isoflurane to either of the following spontaneous eye opening, grimacing, spontaneous limb movement or crying. Any delayed anaesthetic emergence (recovery time > 20 min) will be recorded. In all the children, pain will be assessed using the paediatric observational FLACC pain scale score with its 0-10 score range, upon arrival in the PACU then every 30 min for 2 h and then at 1 h intervals till 6 h. Duration of postoperative analgesia will be defined as “the time interval beginning from the end of anaesthesia to the time the child had a FLACC score ≥ 4. If 2 coupled observations separated by 5 minute waiting period yielded a FLACC pain scale score at any time to be ≥4, intravenous paracetamol 15 mg/kg will be administered as rescue analgesia to achieve the FLACC score of less than 4. Patients will be observed for 20 minutes after intravenous paracetamol. If FLACC pain scale score remains ≥4, children will be given 0.5 microgram/kg of fentanyl intravenously. The same dose will be repeated in increments of 0.5mcg/kg till maximum of 2 mcg/kg/hr. The duration of analgesia and the total analgesic administered over 24 hours will be recorded. After transfer of patients to the ward, pain scores will be documented at 8, 12, 16, 20 and 24 h postoperatively.The motor block will be assessed using Modified Bromage scale on awakening followed by every 15 min till resolution of block by asking the children to flex their knees and ankles or by eliciting the leg movement by tickling toes in younger children who were unable to follow commands. The duration of motor block, that is, time from administration of caudal block to the time when child begins to move the legs with full flexion of knees and feet, will be recorded.PONV will be assessed on the basis of 4-point objective score. If score is >2 patient will be consoled and treated with Inj. Dexamethasone 0.1 mg/kg intravenously. Side effects like bradycardia, hypotension, desaturation, excessive sedation, pruritis, urinary retention will be recorded and treated accordingly. The children will be shifted to the ward 6 h after surgery.In the ward the children will be followed up by the investigator and the nurse for 24 hrs with respect to FLACC pain scores (on arrival to ward, at 8, 12, 16, 20 and 24 hours postoperatively).**Duration of treatment** – Up to 24 hours postoperatively**Dosages of drug:** 1 mcg/ kg caudal Dexmedetomidine with 0.2% ropivacaine with intranasal saline in group C and intranasal 1mcg/kg dexmedetomidine with caudal block with ropivacaine (1ml/kg) in group N**SCORES specifically related to Protocols:**FLACC pain score for post operative analgesia, 4 point objective score for PONV , Ramsay sedation score for the level of sedation , WATCHA scale for emergence delirium, Modified Aldrete score achieved at the end of 6 hours postoperatively.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 63
patient Aged 1-8 years,ASA physical status I/II, undergoing infraumbilical surgeries under general anaesthesia.
- 1.Parental /guardian refusal for inclusion in the study 2.Known allergy to amide local anaesthetics or dexmedetomidine.
- 3.Pre-existing cardiovascular, respiratory or neurological disease 4.History of developmental delay or mental retardation which could make observational pain intensity assessment difficult 5.Children with conduction blocks 6.Known or suspected coagulopathy 7.Anatomical abnormalities of spine and sacrum.
- 8.Local infection at caudal puncture site 9.Rhinitis and nasal polyp 10.Patients with age < 1 years and >7 years 11.ASA grade III/IV.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the duration of postoperative analgesia ie. the time when the first analgesic is required postoperatively Immediate postoperative to over 24 hours after surgery
- Secondary Outcome Measures
Name Time Method To compare the following parameters between 2 groups 1.Postoperative emergence delirium using WATCHA score
Trial Locations
- Locations (1)
All India Institute of Medical Sciences,New Delhi
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences,New Delhi🇮🇳Delhi, DELHI, IndiaAyushi AgarwalPrincipal investigator7726881619ayushiagarwalsgnrsgnr@gmail.com