| CTRI Number |
CTRI/2025/11/097174 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two drugs added to local anaesthetic for pain relief in children undergoing cleft palate surgeries. |
|
Scientific Title of Study
|
Comparative Evaluation of dexmedetomidine versus dexamethasone as an adjuvant to bupivacaine in bilateral suprazygomatic maxillary nerve block for postoperative analgesia in children undergoing cleft palate surgeries : A Randomized, Prospective, Double-Blind 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 |
Amanpreet Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ANAESTHESIOLOGY AIIMS New Delhi, Ansari nagar east , New delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
8491934981 |
| Fax |
|
| Email |
166oberoi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sneha Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ANAESTHESIOLOGY AIIMS New Delhi, Ansari nagar east , New delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
9919625952 |
| Fax |
|
| Email |
drsinghsneha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amanpreet Singh |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Department of ANAESTHESIOLOGY AIIMS New Delhi, Ansari nagar east , New delhi, 110029
New Delhi
DELHI
110029
India |
| Phone |
8491934981 |
| Fax |
|
| Email |
166oberoi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS New Delhi, Ansari Nagar East , New Delhi ,110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS New Delhi |
AIIMS ,Ansari Nagar East , New Delhi , 110029,INDIA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amanpreet Singh |
AIIMS New Delhi, Burns And Plastic Surgery block |
Operation Theatre Complex, 7th floor, Burns and Plastic Surgery Block, AIIMS New Delhi, Ansari nagar east , New delhi, 110029
New Delhi
DELHI |
08491934981
166oberoi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q00-Q99||Congenital malformations, deformations and chromosomal abnormalities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group DM |
will receive 1-2 mL of a solution containing 0.15 mL /kg of 0.25% bupivacaine with 0.1 mg/kg of dexamethasone on each side |
| Intervention |
Group DX |
will receive 1-2 mL of a solution containing 0.15 mL /kg of 0.25% bupivacaine with 0.5 µg /kg of dexmedetomidine on each side |
|
|
Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Children posted for elective cleft palate repair under general anaesthesia
Aged between 8 months to 5 years
ASA category I and II
Willing to give consent
|
|
| ExclusionCriteria |
| Details |
Lack of Parental consent
Allergic to local anesthetics
Coagulation disorders
Local infection or lesion at the proposed puncture site
Language difficulties
Cognitive disorders
Comorbid conditions like congenital heart diseases airway obstruction disease and central nervous system disorders
|
|
|
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 |
Time for first rescue analgesia
Duration of analgesia
|
Time for first rescue analgesia 24 hours
duration of analgesia 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative FLACC score
Total Postoperative fentanyl consumption
Parental satisfaction scale (LIKERT)
Intraoperative & total opioid use |
4HRS 8HRS 16HRS 20HRS 24HRS
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is a randomized, prospective, double-blind clinical trial designed to compare the effectiveness of dexmedetomidine and dexamethasone as adjuvants to bupivacaine in bilateral suprazygomatic maxillary nerve blocks for providing postoperative analgesia in children undergoing cleft palate surgery. The aim is to evaluate which adjuvant offers superior pain relief, longer duration of analgesia, and better safety profile in the pediatric population, thereby contributing to improved postoperative outcomes and reduced need for systemic analgesics. |