| CTRI Number |
CTRI/2025/01/079431 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Compare intravenous paracetamol as pre-emptive vs preventive analgesic on post operative pain in open elective below umbilical surgeries under general anaesthesia in paediatric patients. |
|
Scientific Title of Study
|
A prospective randomised study to compare intravenous paracetamol as preemptive vs preventive analgesic on postoperative pain in open elective below umbilical surgeries under general anaesthesia in paediatric patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mushahid Raza Khan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru Medical College,Aliagrh Muslim University |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal nehru Medical College,Aliagrh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8791805825 |
| Fax |
|
| Email |
khanmushahid83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shahna Ali |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal nehru Medical College,Aliagrh Muslim University |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal nehru Medical College,Aliagrh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9411979684 |
| Fax |
|
| Email |
drshahna.farhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mushahid Raza Khan |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal nehru Medical College,Aliagrh Muslim University |
| Address |
Department of Anaesthesiology and Critical care, Jawaharlal nehru Medical College,Aliagrh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8791805825 |
| Fax |
|
| Email |
khanmushahid83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care,Jawaharlal Nehru Medical College,Aligarh Muslim University,Aligarh-202002, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal nehru medical collage AMU |
| Address |
Department of Anaesthesiology and critical care Jawaharlal Nehru Medical Collage Aligarh Muslim University, Aligarh-202002, Uttar Pradesh, India |
| 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 |
| Dr Mushahid Raza Khan |
Jawaharlal Nehru Medical College,Aligarh Muslim University |
Department of Anesthesiology and Critical Care,Aligarh
Aligarh
UTTAR PRADESH |
8791805825
khanmushahid83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee (Regd)Jawaharlal Nehru Medical Collage |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q541||Hypospadias, penile, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection.Paracetamol |
Group PE (Pre-emptive group) will be given 15 mg/kg of intravenous paracetamol in 20 mL of normal saline over 5mins; 15mins before induction of GA. |
| Comparator Agent |
Injection.paracetamol |
Group PV (Preventive group) will be given 15 mg/kg of intravenous paracetamol in 20 mL of normal saline after closure. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
weight more than 10kgs
open abdominal surgeries
operation time less than 120 minutes
ASA 1 and ASA2 |
|
| ExclusionCriteria |
| Details |
1) Refusal of patients attendant/guardian
2) psychiatric illness.
3) H/O allergy /hypersensitivity to paracetamol, NSAIDS
4) Haemodynamically unstable patients.
5) Hepatic and renal dysfunctions
6) Use of anticoagulants.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue paracetamol after extubation |
1 hr, 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total paracetamol consumption in 24hours post surgery(mg)
2. Total number of patients requiring rescue paracetamol
3. Total number of patients requiring Break through analgesic (Ketorol) and Total Ketorol consumption(mg)
4. Pain score at 1hour in PACU and cumulative pain score at 24 hours
5. Side effects (vomiting, bleeding from site, stomach ache, hematemesis, allergy, anaphylactic reaction)
6. Parental satisfaction evaluated using a five-point Likert scale (very satisfied: 5, satisfied: 4, neutral: 3, dissatisfied: 2, and very dissatisfied: 1)
|
1hr, 24hr |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/02/2025 |
| 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
|
Background: Managing postoperative pain in children is challenging due to their limited ability to express pain and the risks of traditional analgesics like opioids and NSAIDs. Intravenous paracetamol is a safer alternative with proven efficacy. Pre-emptive analgesia (administering analgesics before surgical trauma) may reduce pain and analgesic needs compared to preventive analgesia (after surgery). Purpose: The trial compares the effectiveness of intravenous paracetamol given pre-emptively versus preventively on postoperative pain in pediatric patients undergoing elective open below-umbilical surgeries under general anesthesia. Objectives: • Primary: Time to first rescue paracetamol dose. • Secondary: Total analgesic consumption, pain scores, side effects, and parental satisfaction within 24 hours post-surgery. |