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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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