| CTRI Number |
CTRI/2016/09/007326 [Registered on: 30/09/2016] Trial Registered Prospectively |
| Last Modified On: |
29/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Diclofenac (nonsteroidal anti inflammatory drug) versus pentazocine (opioid analgesic) for pain relief in acute pancreatitis |
|
Scientific Title of Study
|
A randomised controlled trial to compare efficacy of diclofenac with pentazocine for relief of abdominal pain in patients with acute pancreatitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pramod Kumar Garg |
| Designation |
Proffessor of gastroenterology |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9868397205 |
| Fax |
|
| Email |
pgarg10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Jagannath Mahapatra |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9990420767 |
| Fax |
|
| Email |
soumyajagannath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Jagannath Mahapatra |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9990420767 |
| Fax |
|
| Email |
soumyajagannath@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi, 110021 |
| 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 |
| Dr Pramod Garg |
All India Institute of Medical Sciences |
Department Of Gastroenterology and Human Nutrition
South
DELHI |
9868397205
pgarg10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, All India Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, patients with acute pancreatitis diagnosed as per revised Atlanta classification within 7 days of onset of illness , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diclofenac Sodium (NSAID) |
It is to be given 75 mg intravenous route every 8 hourly till 40 hours. |
| Comparator Agent |
Pentazocine (opoid analgesic) |
It is to be given 30 mg intravenous route every 8 hourly till 40 hours. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patients with acute pancreatitis diagnosed as per revised Atlanta classification will be included.Patients should have abdominal pain at enrollment and should be hospitalised within 7 days of onset of acute pancreatitis |
|
| ExclusionCriteria |
| Details |
1. Patients with organ failure (as defined by revised Atlanta classification) at enrollment
2. Patients with altered sensorium
3. Patients with a serum creatinine > 1.5 mg/dl
4. Patient with a known coronary artery disease
5. Patients admitted after 7 days of onset of acute pancreatitis
6. Patients with paralytic ileus as defined by abdominal distention, absent bowel sounds and dilated loops on intestine
7. Patients with evidence of chronic pancreatitis
8. Refusal to give consent
9. Age < 18 year or > 75 year |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Difference in efficacy of interventional analgesics for pain relief in terms of total dose and number of bad demands of rescue analgesia
2. The need for crossover of intervention analgesic |
From enrollment till 40 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in adverse events between the groups |
from enrollment till 5 days |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2016 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acute pancreatitis is an inflammatory condition of pancreas which is associated with significant abdominal pain. Relief of pain is an important component of management of patients with pancreatitis which can be achieved either by opioid analgesics or NSAIDs. Though both are effective for pain relief, NSAIDs have additional anti inflammatory property. There are only few studies either on NSAIDs or on opioids for pain relief in patients with acute pancreatitis. Also there is no definite recommendation for the most suitable analgesic for pain relief in acute pancreatitis. Hence, the present study is designed to compare diclofenac, an NSAID, with pentazocine, an opioid, for pain relief in patients with acute pancreatitis. |