| CTRI Number |
CTRI/2025/08/093524 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dexmedetomidine as an adjuvant to ropivacaine infiltration for postoperative analgesia in pediatric tonsillectomy:a randomised controlled study |
|
Scientific Title of Study
|
Comparison of ropivacaine local infiltration with and without dexmedetomidine for post- operative analgesia in children undergoing tonsillectomy:a randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College,New Delhi |
| Address |
Room No. 415,BL Taneja Block ,Department of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002
Central
DELHI
110002
India |
| Phone |
6375539723 |
| Fax |
|
| Email |
jangirpooja70@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahil Singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College,New Delhi |
| Address |
Room No. 415,BL Taneja Block ,Department of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahil Singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College,New Delhi |
| Address |
Room No. 415,BL Taneja Block ,Department of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002
Central
DELHI
110002
India |
| Phone |
9810719025 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, Jawaharlal Nehru Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, 2, Bahadur Shah Zafar Marg, New Delhi,110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja |
Lok Nayak Hospital |
Otorhinolaryngology OT, Third floor,Operation Theater Block,Department of Anaesthesiology , Lok Nayak Hospital,JLN Marg,Delhi,110002
Central
DELHI |
6375539723
jangirpooja70@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Maulana Azad Medical College and Associated Hospitals,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine |
Peritonsillar infiltration with 0.20% ropivacaine (total volume 5.5 mL) without dexmedetomidine 1 mcg/kg, administered intraoperatively after induction of general anaesthesia and before incision, under aseptic precautions. |
| Intervention |
Ropivacaine+Dexmedetomidine |
Peritonsillar infiltration with 0.20% ropivacaine (total volume 5.5 mL) combined with dexmedetomidine 1 mcg/kg, administered intraoperatively after induction of general anaesthesia and before incision, under aseptic precautions. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patient Aged 4-12 years with American Society of Anaesthesiologists physical status I-II
|
|
| ExclusionCriteria |
| Details |
Children with allergy to study drugs, requiring additional surgery, having intellectual disability affecting pain assessment, or with significant cardiac/respiratory disease will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia, defined as the time from completion of surgery to the first request for postoperative rescue analgesic. |
From arrival in the PACU and monitored until 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative Wong–Baker FACES pain scores |
on PACU arrival, 30 min, 6 h, 12 h, 18 h, 24 h, and 1 week post-op. |
| Total rescue analgesic consumption |
Cumulative amount over first 24 hours post op |
| Intraoperative blood loss in ml |
Measured during surgery |
| Emergence delirium PAED score |
At 0, 5, 10, 15 and 20 minutes after PACU interval |
| Parents postoperative pain measure - PPMP |
At 24 hours and 1 week post op |
| Surgeons satisfaction score- Likert 5 point |
At 24 hours post op |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized, double-blind, controlled study aims to compare the efficacy of peritonsillar infiltration with 0.20% ropivacaine and 1 mcg/kg dexmedetomidine versus 0.20% ropivacaine alone for postoperative analgesia in children aged 4–12 years undergoing tonsillectomy. The primary objective is to compare the duration of analgesia between the two groups. Secondary objectives include comparing postoperative pain scores, total rescue analgesic consumption, intraoperative blood loss, incidence and severity of emergence delirium, parental pain assessment, and surgeon satisfaction. We hypothesize that adding dexmedetomidine to ropivacaine will prolong analgesia and improve postoperative recovery without increasing adverse effects. |