TO COMPARE THE EFFICACY OF TWO ANALGESICS:DICLOFENAC AND TRAMADOL IN RELIEVING PAIN IN PATIENTS OF ACUTE PANCREATITIS â€“ A PILOT STUDY

Completed

Brief Summary: Total of 41 patients were randomised (20 in diclofenac and 21 in tramadol group).There was no difference in total number of painful days, number of severe painful days, number of days taken to reduce severity of pain and total number of times rescue drug was used between two groups. Improvement in pain scores at day 7 was comparable between diclofenac and tramadol groups. Adverse events were also comparable between two groups with exception of slightly higher vomiting in tramadol group.

Recruitment & Eligibility

Inclusion Criteria

Informed consent.
Patients more than 18 years of age.
3.Acute pancreatitis as defined by clinical symptoms, elevated serum amylase (more than thrice the upper limit of normal range) or imaging findings.
Patients who have presented to the hospital within the first 3 days after onset of pain.
Alert and oriented at admission.

Exclusion Criteria

Pregnancy 2.
Patients with significant chronic hepatitis, anaemia and agranulocytosis.
3.Patients of acute pancreatitis who have renal failure (Serum Creatinine â‰¥ 1.4 mg/dl) at presentation 4.Patients who were contraindicated to Opioids and NSAIDS 5.
Patients Who already are taking or have taken opioids and NSAIDS for other reasons ïƒ˜No written informed consent ïƒ˜Deaths during study.

Primary Outcome Measures

Name	Time	Method
1.Number of participants showing improvement in pain intensity.	Pain scores were recorded after first hour (VAS1) of administration of the drug and subsequently every 3 hours by a blinded researcher using the VAS for assessing pain intensity. \| The study medication was limited to maximum period of seven days and stopped earlier if there was no further need for analgesia. A painless day was defined as being a day when a patient mark zero on VAS.
2.Number of participants requiring supplementary analgesia (offered when trial drug intervention fails to relieve pain).	Pain scores were recorded after first hour (VAS1) of administration of the drug and subsequently every 3 hours by a blinded researcher using the VAS for assessing pain intensity. \| The study medication was limited to maximum period of seven days and stopped earlier if there was no further need for analgesia. A painless day was defined as being a day when a patient mark zero on VAS.

Secondary Outcome Measures

Name	Time	Method
1.Number of participants with pancreatitis complications.	2.Number of participants with drug related adverse events.

Locations (1): PGIMER, Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
RAKESH KOCHHAR
Principal investigator
9815699565
dr_kochhar@hotmail.com