| CTRI Number |
CTRI/2025/02/080121 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison between tramadol and diclofenac for pain relief in case of acute pancreatitis |
|
Scientific Title of Study
|
A randomized controlled trial to compare between tramadol and diclofenac for achieving analgesia in patients of acute pancreatitis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ARUNAVA SARKAR |
| Designation |
POST DOCTORAL TRAINEE GASTROENTEROLOGY |
| Affiliation |
IPGMER AND SSKM |
| Address |
Room no 24 4th floor Ronald ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Room no 24 4th floor Ronald ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
09474464536 |
| Fax |
|
| Email |
arunavanrs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEBASHIS MISRA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
IPGMER AND SSKM |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830472292 |
| Fax |
|
| Email |
debcnmch@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEBASHIS MISRA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
IPGMER AND SSKM |
| Address |
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Room no 24 4th floor Ronald Ross Building IPGMER and SSKM Hospital 244 AJC Bose Road Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830472292 |
| Fax |
|
| Email |
debcnmch@yahoo.com |
|
|
Source of Monetary or Material Support
|
| IPGMER and SSKM Hospital Kolkata room no 24 Ronald ross IPGMER and SSKM Hospital 244 AJC Bose road Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
IPGMER AND SSKM |
| Address |
Room no 24 4th floor Ronald ross building IPGMER and SSKM Hospital 244 AJC Bose road kolkata 700020 |
| 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 Arunava Sarkar |
School of Digestive and Liver Disease |
Room no 24 ,School of Digestive and Liver disease IPGMER AND SSKM HOSPITAL 244 AJC BOSE ROAD KOLKATA
Kolkata
WEST BENGAL |
09474464536
arunavanrs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER RESEARCH OVERSIGHT COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K859||Acute pancreatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection Diclofenac |
Patient shall receive injection Diclofenac 1 mg per kg body weight diluted in 100 ml normal saline and infused over 30 minutes through intravenous route every 8 hourly for 24 hours with maximum 50 mg per dose and maximum 150 mg per day |
| Intervention |
injection Fentanyl |
injection Fentanyl will be used as rescue analgesia in both group of patient receiving either tramadol or diclofenac and will be delivered by intravenous route through patient controlled analgesia pump with demand dose of 0.3 microgm per kg body weight and a lock out interval of 15 minutes |
| Intervention |
injection Tramadol |
Patient shall receive injection Tramadol 1 mg per kg body weight diluted in 100 ml normal saline and infused over 30 minutes through intravenous route every 8 hourly for 24 hours with maximum 100 mg per dose and maximum 300 mg per day . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of acute pancreatitis diagnosed as per revised Atlanta classification with two out of the following three points 1. abdominal pain consistent with acute pancreatitis 2. Serum lipase or amylase activity at least three times greater than upper limit of normal 3. Characteristics imaging finding on trans abdominal ultrasound or contrast enhanced computed tomography of abdomen or magnetic resonance imaging of pancreas. The patient diagnosed as acute pancreatitis should be 1.present with in 7 day of pain onset 2.presents with pain abdomen with visual analogue score 3 or more and 3. normal sensorium as defined by Glasgow coma score 15. |
|
| ExclusionCriteria |
| Details |
Age less than 18 and more than 75.
Patient with evidence of chronic pancreatitis.
Patient with shock requiring vasopressor.
Patient with respiratory failure requiring mechanical ventilation.
Patient with serum creatinine more than equal to 1.5 mg per dl.
Patient with coronary artery disease.
Patient with altered sensorium with Glasgow coma scale less than 15.
Patient refuses to give consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To measure the difference in efficacy of tramadol and diclofenac in pain relief in patients of acute pancreatitis. |
40 hours and 3 days of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the difference in the adverse events between the diclofenac and tramadol group.
|
3 days of follow up |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/02/2025 |
| 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)
|
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
|
This is a randomized controlled trial that will be conducted in admitted patients in Division of Gastroenterology School of Digestive and Liver disease of Institute of Post Graduate Medical Education and Research kolkata India. This study will be double blind parallel group 1 :1 allocation randomized controlled trial that will be conducted from February 2025 to October 2026. After inclusion and exclusion criteria are met ,patient are admitted in indoor. They are randomized to receive either medication A/B (diclofenac/tramadol). Study medication A or B will be decided and fixed as either diclofenac or tramadol by independent doctor not associated with the study. Patient will receive injection diclofenac or injection tramadol diluted in 100 ml normal saline and run every 8 hourly over 30 minute for 24 hours. Fentanyl will be used as rescue analgesia in both the groups and will be delivered through patient controlled analgesia pump. The demand dose of fentanyl is 0.3 microgram per kg and lock out interval 15 minutes. So after a bolus dose taken by patient ,the next dose will be delivered after 15 minutes. Patient will be instructed to press the button of the pump when he feels pain. Those delivered dose will be counted by the pump as effective dose and those not delivered will be counted by ineffective dose. If the total number of ineffective dose is 24 or more at the end of 24 hours then the study medication will be crossed over and the cross over drug will be given for 2 dose 8 hr apart. Thus the study ends at 24 hours if there is no cross over and at 40 hours if there is cross over. The total number of effective , ineffective demands, total dose of fentanyl, pain free time will be measured. Pain will also be recorded on visual analogue scale and noted at starting, 4 hours, 12 hours,18 hours,24 hours and 6 hourly if cross over happens. Assessment of pain relief will be compared in terms of 1. total dose of fentanyl, 2. duration of time measured when patient did not require rescue analgesia,3 total number of effective and ineffective demands. Also pain by Visual analogue score will be compared. Need of crossover will be recorded. For adverse events comparisons any new change in haematological or biochemical parameter will be documented. Particularly following adverse events will be noted -nausea and vomiting, paralytic ileus, altered sensorium, respiratory depression, gastrointestinal bleeding, and acute kidney injury. All findings will be expressed in text, tables and graphs. Data will be presented as mean (s.d.) or median ( IQR) as appropriate. The Student t test shall be used for continuous variables. The Chi Square test or Fisher exact test for a 2 tailed p value shall be used to compare the qualitative data between two groups. The Wilcoxon rank sum test will be used for comparing non parametric variables with in a group. Mann - Whitney U test will be used for comparing non parametric variables between the groups. An intention to treat analysis will be performed to compare the data. Two tailed p value of less than 0.005 will be called significant. |