| CTRI Number |
CTRI/2025/10/096517 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Easing Surgery Stress in Children: Which Works Best—Medicine or Play? |
|
Scientific Title of Study
|
Comparing the Quality of Recovery after Melatonin, Midazolam, or Play Therapy in Paediatric Laparoscopic Surgery with Caudal Block : A Prospective Randomized 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 |
Nishant Patel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nishant Patel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishant Patel |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi
DELHI
110029
India |
| Phone |
8510955882 |
| Fax |
|
| Email |
pateldrnishant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, New Delhi, India, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nishant Patel |
AIIMS, New Delhi |
Department of Anesthesia, Pediatric operation theatre no 13,14,15
South West
DELHI |
08510955882
pateldrnishant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R10-R19||Symptoms and signs involving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Melatonin group (Group B) |
Oral melatonin 0.5 mg/kg (max 6 mg) administered 45 minutes before induction (total duration of intervention 45 minutes) |
| Intervention |
Midazolam group (Group A) |
IV midazolam 0.05–0.1 mg/kg (max 2 mg) administered, 10 minutes before induction (total duration of intervention is 10 minutes) |
| Comparator Agent |
Non-pharmacological play therapy group (Group C) |
30-minute structured play therapy session 45 minutes before induction, delivered by a trained nurse or anesthesia resident. The session will include medical play, coping-skill rehearsal, and parental coaching ( total duration of intervention 45 minutes) |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 5–15 years (either gender)
ASA physical status 1-2
Scheduled for elective infra-umbilical laparoscopic abdominal surgery ( appendectomy, hernia repair, orchidopexy)
Informed consent from parent/guardian and assent from child when appropriate
|
|
| ExclusionCriteria |
| Details |
Known allergy to study drugs or local anesthetics
Coagulopathy or local infection at block site
Congenital spinal anomaly
Significant cardiac conduction abnormality
Developmental delay or cognitive impairment precluding questionnaire completion
Obstructive sleep apnea requiring admission
Active respiratory infection
Anticipated need for postoperative ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare Paediatric Quality of Recovery (PedSQoR) scores between 24 hours preoperatively(baseline) and 24 hours post-surgery among children receiving melatonin, midazolam, or play therapy preoperatively in addition to a standardized caudal block |
preoperatively- 24 hrs before surgery
postoperatively- 24 hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the incidence of perioperative anxiety mYAPS score in each group before induction
PACU Face, Legs, Activity, Cry, & Consolability FLACC pain scores at arrival, 15, 30, 60 minutes
Total perioperative opioid consumption (µg/kg)
Time to first rescue analgesic
Emergence delirium- Paediatric Anesthesia Emergence Delerium PAED score in PACU
Incidence of PONV
Length of hospital stay
Parental satisfaction score at 24 hours (5-point Likert scale)
Adverse events: paradoxical agitation, bradycardia/hypotension, desaturation, block-related complications, Local Anesthesia Systemic toxicity (LAST )
|
During surgery, 24 hrs post surgery & 48 hrs post surgery |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
10/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/11/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a randomized, multiple-arm, parallel-group clinical trial comparing three different preoperative preparation methods—oral melatonin, intravenous midazolam, and non-drug play-based activities—in children undergoing laparoscopic abdominal surgery under general anesthesia with a caudal block. The main aim is to evaluate and compare the children’s quality of recovery after surgery using a validated pediatric recovery questionnaire. All participants will be randomly assigned to one of the three groups, receive the assigned intervention before surgery, and be monitored during and after the procedure at 24 and 48 hrs for recovery quality, comfort, and any side effects. This study will help identify which method best supports a smooth and comfortable recovery in pediatric patients. |