A study to find the effectiveness of two drugs, Diclofenac and Buprenorphine to help relieve pain in patients who develop acute inflammation of the pancreas, namely pancreatitis

Phase 4

Completed

Conditions: Acute pancreatitis, unspecified,

Registration Number: CTRI/2020/07/026914

Lead Sponsor: Mayank Saini

Brief Summary: This study is a Randomized, double blind, parallel group, single centre trial, comparing the efficacy of diclofenac,(75 mg 8 hourly) and buprenorphine(0.3 mg 8 hourly), both given for 40 hours, in 48 patients of Acute Pancreatitis, who present to PGIMER Chandigarh. Fentanyl via a patient controlled analgesia(PCA) pump will be given in both group of patients and objective methods will be utilised to assess pain relief.The primary outcome measures will be the difference in the dose of fentany required and the difference in the number of effective and ineffective demands in the diclofenac and buprenorphine group,measured at 24, 48 and 72 hours. The secondary outcomes will be the difference in the pain free interval , mean VAS scores and adverse events in the diclofenac and buprenorphine groups as well as the development of organ failure, assessed using Marshall scoring, during the 72 hours time period.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 48

Inclusion Criteria

Acute pancreatitis as defined by the clinical symptoms, elevation in serum amylase level(more than three times the upper limit of normal range) or imaging finding Abdominal pain at the time of enrolment Patients who have presented to the hospital within the first 5 days after onset of pain.

Exclusion Criteria

Pregnancy Patients of acute pancreatitis who have renal failure (Serum Creatinine > 1.5 mg/dl) at presentation Patients who were contraindicated to Opioids and NSAIDS Who already take Opioids and NSAIDS for other reasons Patients with history of coronary artery disease Patients with altered mental status Patients with imaging evidence of chronic pancreatitis Patients requiring ventilatory support.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Difference in the number of effective and ineffective demands in diclofenac and buprenorphine group	24 hours, 48 hours, 72 hours
1. Difference in the dose of fentanyl required in diclofenac and buprenorphine group	24 hours, 48 hours, 72 hours

Secondary Outcome Measures

Name	Time	Method
1.Difference in the pain free interval in diclofenac and buprenorphine group	24, 48 and 72 hours
Difference in the mean VAS score in the diclofenac and buprenorphine group	24, 48 and 72 hours
The difference in the adverse events between the 2 groups	72 hours
The development of organ failure, assessed using the Marshall scoring	72 hours

Trial Locations

Locations (1): PGIMER, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
Jayanta Samanta
Principal investigator
9855319529
dj_samanta@yahoo.co.in