| CTRI Number |
CTRI/2024/06/068751 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Tramadol vs Paracetamol for Pain Relief in Acute Pancreatitis: A Randomized Controlled Trial |
|
Scientific Title of Study
|
To Compare the Efficacy and Safety of Intravenous Tramadol versus Intravenous Paracetamol as Analgesics in Patients of Acute Pancreatitis: A Prospective, Randomized Control Trial |
| 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 ABHIJEET SHRIDHAR |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college and hospital Aligarh muslim University |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9899859153 |
| Fax |
|
| Email |
geniusabhijeet97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR JAMEEL AHMAD |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7599529550 |
| Fax |
|
| Email |
ahmad.drjameel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JAMEEL AHMAD |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university
UTTAR PRADESH
202002
India |
| Phone |
7599529550 |
| Fax |
|
| Email |
ahmad.drjameel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh
Uttar Pradesh,202002,India
|
|
|
Primary Sponsor
|
| Name |
DR ABHIJEET SHRIDHAR |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university |
| Type of Sponsor |
Other [] |
|
|
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 ABHIJEET SHRIDHAR |
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university |
Department of Pharmacology and CCW and wards of Department of Medicine
Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim university
Aligarh
UTTAR PRADESH |
9899859153
geniusabhijeet97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTE |
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 |
| Intervention |
paracetamol |
paracetamol I.V 1000mg/100ml Normal Saline three times a day for 7 days |
| Comparator Agent |
tramadol |
tramadol I.V 50mg/100 ml Normal Saline three times a day for 7day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18 or more, with diagnosis of Acute Pancreatitis, Irrespective of severity
2. Acute pancreatitis will be diagnosed according to revised Atlanta Classification 2012, which require 2 or more of the following criteria be met for the diagnosis;
(a) Abdominal pain suggestive of pancreatitis
(b) Serum amylase or lipase level greater than three times the upper normal value
(c) Characteristic imaging findings
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe hepatic impairment & severe renal impairment (Creatinine clearance less than 30mL/min)
2. Ongoing treatments with NSAIDs (within 24hrs)
3. History of allergy to paracetamol and/or tramadol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To Determine the effectiveness of Intravenous Paracetamol and Intravenous Tramadol in treating pain.
2. To Compare. pain alleviation between Paracetamol and Tramadol
3. Analyzing patient-reported pain intensity outcomes
4. Potentially assessing adverse events or adverse drug reactions with Paracetamol and Tramadol
|
18-24 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The duration of pain alleviation provided by Tramadol & Paracetamol
2. Assessing the impact of these medications on hospital stays or re-admission rates
3. Examining overall patient satisfaction with pain management
|
18-24 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
24/06/2024 |
| 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="2"
Months="0"
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
|
patient will be randomized 1:1 and one group will receive iv paracetamol 1000 mg/100 ml, and another group will get iv tramadol 50 mg/100 ml NS and will be monitored at 24 hours, 48 hours, 72 hours, and 7 days. Radiological investigations (USG, CT, MRCP) will determine the severity of Acute Pancreatitis as per the Revised Atlanta Classification 2012 (mild, moderate to Severe, Severe). Extensive laboratory tests like CBC, LFT, ABG, Urine- analysis, lipid profile, blood glucose, GGT, serum procalcitonin, SGPT, SGOT, serum bilirubin (direct, indirect, and total), serum amylase, and serum lipase will be conducted. Pain intensity will be assessed using a Visual Analogue Scale at the baseline and at 24 hours, 48 hours, 72 hours, and 7 days if possible, with recorded changes. The comprehensive approach provides insights into the effectiveness of IV paracetamol and Tramadol in managing pain among patients with acute pancreatitis, regardless of severity. It also evaluates secondary outcomes, including duration of pain relief, impact on hospital stays, and patient satisfaction with pain management. |