A randomized controlled trial to compare between tramadol and diclofenac for achieving analgesia in patients of acute pancreatitis.

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.