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CTRI Number  CTRI/2018/05/014309 [Registered on: 31/05/2018] Trial Registered Retrospectively
Last Modified On: 12/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   TO COMPARE THE EFFICACY OF TWO ANALGESICS:DICLOFENAC AND TRAMADOL IN RELIEVING PAIN IN PATIENTS OF ACUTE PANCREATITIS – A PILOT STUDY 
Scientific Title of Study   TO COMPARE THE EFFICACY OF DICLOFENAC AND TRAMADOL IN RELIEVING PAIN IN PATIENTS OF ACUTE PANCREATITIS – A PILOT STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rakesh Kochhar 
Designation  Professor and Head of Department 
Affiliation  PGIMER chandigarh 
Address  Department of Gastroenterology PGIMER CHANDIGARH
Department of Gastroenterology
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  dr_kochhar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rakesh Kochhar 
Designation  Professor and Head of Department 
Affiliation  PGIMER chandigarh 
Address  Department of Gastroenterology PGIMER CHANDIGARH
Department of Gastroenterology
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  dr_kochhar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Kumar Nadipalli 
Designation  Former MD Medicine resident 
Affiliation  PGIMER chandigarh 
Address  Department of Gastroenterology PGIMER CHANDIGARH
Department of Gastroenterology
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  santosh.nadipalli@gmail.com  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research Chandigarh- 160012 
 
Primary Sponsor  
Name  PGIMER 
Address  sector 12 chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 
RAKESH KOCHHAR  PGIMER, Chandigarh  Patients recruited from Emergency, General, Private ward, Intensive care units- Main ICU, Liver ICU, Respiratory ICU
Chandigarh
CHANDIGARH 		 9815699565

dr_kochhar@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution ethics committee postgraduate institute of medical education and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pain in Acute pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous diclofenac  Intravenous diclofenac 1 mg/kg was administered in adult patients with acute pancreatitis presenting within 3 days of onset of pain as a 2nd comparator arm of this RCT. 
Comparator Agent  Intravenous tramadol   Intravenous tramadol 1 mg/kg 12 hourly was administered in adult patients with acute pancreatitis presenting within 3 days of onset of pain. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Informed consent.
2. Patients more than 18 years of age.
3.Acute pancreatitis as defined by clinical symptoms, elevated serum amylase (more than thrice the upper limit of normal range) or imaging findings.
4. Patients who have presented to the hospital within the first 3 days after onset of pain.
5. Alert and oriented at admission.
 
 
ExclusionCriteria 
Details  1. Pregnancy
2. Patients with significant chronic hepatitis, anaemia and agranulocytosis.
3.Patients of acute pancreatitis who have renal failure (Serum Creatinine ≥ 1.4 mg/dl) at presentation
4.Patients who were contraindicated to Opioids and NSAIDS
5. Patients Who already are taking or have taken opioids and NSAIDS for other reasons
No written informed consent
Deaths during study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Number of participants showing improvement in pain intensity.
2.Number of participants requiring supplementary analgesia (offered when trial drug intervention fails to relieve pain).
 		 Pain scores were recorded after first hour (VAS1) of administration of the drug and subsequently every 3 hours by a blinded researcher using the VAS for assessing pain intensity.
The study medication was limited to maximum period of seven days and stopped earlier if there was no further need for analgesia. A painless day was defined as being a day when a patient mark zero on VAS.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Number of participants with pancreatitis complications.
2.Number of participants with drug related adverse events.
3.To determine correlation between lipase concentration on admission and dose of analgesia requirement.
4.Number of deaths from any cause.
 		 No time point 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2015 
Date of Study Completion (India) 30/11/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication related to this study yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Total of 41 patients were randomised (20 in diclofenac and 21 in tramadol group).There was no difference in total number of painful days, number of severe painful days, number of days taken to reduce severity of pain and total number of times rescue drug was used between two groups. Improvement in pain scores at day 7 was comparable between diclofenac and tramadol groups. Adverse events were also comparable between two groups with exception of slightly higher vomiting in tramadol group.  
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