| CTRI Number |
CTRI/2024/05/066958 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| 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
|
comparison between paracetamol , paracetamol with diclofenac and paracetamol with ketorolac for pain relief after surgery |
|
Scientific Title of Study
|
A comparison of preemptive paracetamol, paracetamol-diclofenac and paracetamol-ketorolac combination on post operative pain
after elective abdominal surgery under general anesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA PARMAR |
| Designation |
PG RESIDENT |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GAJRA RAJA MEDICAL COLLEGE GWALIOR
Gwalior MADHYA PRADESH 474001 India |
| Phone |
7611170162 |
| Fax |
|
| Email |
DRNEHAPARMAR09@GMAIL.COM |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Asish mathur |
| Designation |
ASSOCIATE PROFFESSOR |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GAJRA RAJA MEDICAL COLLEGE GWALIOR
Gwalior MADHYA PRADESH 474001 India |
| Phone |
|
| Fax |
|
| Email |
Ashishgrmc2012@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
NEHA PARMAR |
| Designation |
PG RESIDENT |
| Affiliation |
|
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GAJRA RAJA MEDICAL COLLEGE GWALIOR
Gwalior MADHYA PRADESH 474001 India |
| Phone |
7611170162 |
| Fax |
|
| Email |
DRNEHAPARMAR09@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| GAJRA RAJA MEDICAL COLLEGE GWALIOR MADHYA PRADESH PIN 474001 |
|
|
Primary Sponsor
|
| Name |
GAJRA RAJA MEDICAL COLLEGE GWALIOR |
| Address |
GAJRA RAJA MEDICAL COLLEGE GWALIOR MADHYA PRADESH PIN 474001 |
| 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 Neha Parmar |
JAYAROGYA GROUP OF HOSPITAL Gwalior |
DEPARTMENT OF ANAESTHESIOLOGY AND OT COMPLEX Gwalior MADHYA PRADESH |
7611170162
Drnehaparmar09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) GAJRA RAJA MEDICAL COLLEGE, GWALIOR.M.P. |
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 |
| Intervention |
PARACETAMOL
PARACETAMOL plus DICLOFENAC
PARACETAMOL plus KETOROLAC |
1.infusion paracetamol 1gram iv over 30 minute
2.infusion Paracetamol 1gm iv AND injection Diclofenac 75 mg iv over 30 minute
3.INFUSION Paracetamol 1gm iv AND injection Ketorolac 30mg iv over 30 minute |
| Comparator Agent |
pentazocin |
pentazocin 0.3mg/kg iv over 5 minute |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PHYSICAL GRADE 1 AND 2
WEIGHT 40-90KG |
|
| ExclusionCriteria |
| Details |
Refusal of patient
ASA grade 3 and 4
Uncooperative patients
obesity
steroid therapy
Pregnancy other comorbidities |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| vas score less than 4 in pcm plus ketorolac group |
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pcm plus ketrolac have less side effect than pcm plus diclofenac |
within 24 hour |
|
|
Target Sample Size
|
Total Sample Size="99" Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/05/2024 |
| Date of Study Completion (India) |
01/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/03/2025 |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
A Prospective Randomized Control Study Comparing Preemptive Paracetamol, Paracetamol-Diclofenac, and Paracetamol-Ketorolac for Postoperative Pain After Elective Abdominal Surgery Under General Anaesthesia”
This prospective randomized double-blind controlled study was conducted at the Department of Anaesthesiology, G.R. Medical College & J.A. Group of Hospitals, Gwalior, between April 2023 and March 2025. A total of 99 adult patients of ASA physical status I and II, aged between 20 and 60 years, scheduled for elective abdominal surgeries under general anaesthesia, were enrolled after obtaining informed consent. The patients were randomly allocated into three groups of 33 each. Group P received 1 g intravenous (IV) paracetamol alone, Group PD received 1 g IV paracetamol combined with 75 mg IV diclofenac, and Group PK received 1 g IV paracetamol combined with 30 mg IV ketorolac. All drugs were administered just before surgical incision.
The primary objective of the study was to compare the time to first rescue analgesia among the three groups. Secondary objectives include observation of any adverse drug effects and others like evaluation of postoperative pain using the Visual Analogue Scale (VAS), monitoring of hemodynamic parameters. Standardized general anaesthesia protocols were followed for all patients, and postoperative analgesia was assessed using the VAS at multiple intervals over 24 hours. Rescue analgesia was provided with 100 mg IV tramadol whenever VAS exceeded 4.
The results demonstrated that the group receiving the paracetamol-ketorolac combination (Group PK) experienced significantly prolonged pain-free periods, with delayed requirement for rescue analgesia compared to the other two groups. This group also recorded consistently lower VAS scores during the initial postoperative hours, suggesting superior analgesic efficacy.
The paracetamol-diclofenac group (Group PD) showed intermediate effectiveness, offering better pain relief than paracetamol alone but less than the ketorolac combination. Group P, which received only paracetamol, had the earliest onset of postoperative pain and required earlier rescue analgesia.
Hemodynamic parameters, including heart rate, blood pressure, and oxygen saturation, remained comparable across all groups throughout the observation period, indicating no significant cardiovascular disturbances with any of the analgesic regimens. Adverse effects such as nausea, vomiting, sedation, and shivering were mild and occurred with similar frequency in all groups, with no major complications reported. |