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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

Comparative effects of intravenous Diclofenac and Buprenorphine for pain relief in patients with Acute Pancreatitis : A Randomized Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026914
Enrollment
48
Registered
2020-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K859- Acute pancreatitis, unspecified

Interventions

Intervention1: Buprenorphine: Buprenorphine 0.3 mg intravenous 8 hourly for 40 hours Control Intervention1: Diclofenac: Diclofenac 75 mg Intravenous 8 hourly for 40 hours Control Intervention2: Fentan

Sponsors

Mayank Saini
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1. Difference in the dose of fentanyl required in diclofenac and buprenorphine group 2. Difference in the number of effective and ineffective demands in diclofenac and buprenorphine group Timepoint: 24 hours, 48 hours, 72 hours

Secondary

MeasureTime frame
1. Difference in the pain free interval in diclofenac and buprenorphine groupTimepoint: 24, 48 and 72 hours ;Difference in the mean VAS score in the diclofenac and buprenorphine groupTimepoint: 24, 48 and 72 hours;The development of organ failure, assessed using the Marshall scoringTimepoint: 72 hours;The difference in the adverse events between the 2 groupsTimepoint: 72 hours

Countries

India

Contacts

Public ContactJayanta Samanta

PGIMER, Chandigarh

dj_samanta@yahoo.co.in9855319529

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 10, 2026