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CTRI Number  CTRI/2022/09/045492 [Registered on: 13/09/2022] Trial Registered Prospectively
Last Modified On: 02/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of 2 routes of dexmedetomidine for pain relief in children undergoing infraumbilical surgeries 
Scientific Title of Study   A comparative study to evaluate the analgesic efficacy and safety of caudal versus intranasal dexmedetomidine as an adjuvant to caudal ropivacaine in paediatric patients undergoing infraumbilical surgeries : A Double blind randomised controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayushi Agarwal 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Department of Anaesthesiology,Pain medicine and Critical care,AIIMS ,Ansari Nagar South Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone  7726881619  
Fax    
Email  ayushiagarwalsgnrsgnr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shreya Bharat Shah 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Room no - 6,4th floor ,Porta cabin, Department of Anaesthesiology,Pain medicine and Critical care, ward block ,AIIMS ,Ansari Nagar South Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone  9892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Ayushi Agarwal 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Department of Anaesthesiology,Pain medicine and Critical care,AIIMS ,Ansari Nagar South Delhi

New Delhi
DELHI
110029
India 
Phone  7726881619  
Fax    
Email  ayushiagarwalsgnrsgnr@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences,New Delhi 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  Department of Anaesthesiology,Pain medicine and critical care, AIIMS , Ansari Nagar ,New Delhi ,110029  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ayushi Agarwal  All India Institute of Medical Sciences,New Delhi  Department of Anaesthesiology , Pain medicine and Critical care,AIIMS , South Delhi
New Delhi
DELHI 		 7726881619

ayushiagarwalsgnrsgnr@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS,New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  caudal block  Group C- will receive 1 mcg/kg dexmedetomidine caudally after giving general anesthesia 
Intervention  Intranasal dexmedetomidine  Group N- will receive intranasal dexmedetomidine 1 mcg/kg ; undiluted parenteral preparation (100mcg/ml), equally divided volume instilled into both nostrils after giving general anesthesia 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  patient Aged 1-8 years, ASA physical status I/II, undergoing infraumbilical surgeries under general anaesthesia
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
To compare the following parameters between 2 groups
1. Postoperative emergence delirium using WATCHA score
2. Postoperative sedation using 4-point sedation score
3. Modified Aldrete score 6 hrs postoperatively
4. Total analgesic consumption in first 24 hrs
5. Incidence of side effects like bradycardia , hypotension , nausea-vomiting and desaturation, urinary retention
 		 24 hrs postoperatively 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   13/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
 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 positionGroup 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 postoperativelyDosages 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 NSCORES  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.
 
 
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