Study Comparing Intravenous Paracetamol With Ibuprofen or Metamizole to Treat Pain in Children Aged 3 to 18 With Acute Pancreatitis

What this Trial Is About

This research aims to compare the effectiveness and tolerance of two pain treatments for acute pancreatitis in children aged 3 to 18 years. The study is prospective, interventional, randomized, and sponsored by the Medical University of Warsaw. Children diagnosed with acute pancreatitis based on INSPPIRE criteria and experiencing significant abdominal pain are enrolled to assess which combination provides better pain relief. Participants are randomly assigned to one of two treatment groups. Group A receives intravenous paracetamol at 15 mgkg up to 1000 mg combined with ibuprofen at 10 mgkg up to 400 mg. Group B receives intravenous paracetamol at the same dose combined with metamizole at 15 mgkg up to 100 mg. Pain is assessed before treatment and again 60 minutes after administration using age-appropriate pain scales such as NRS and FLACC. After treatment, pain management continues at the physicians discretion, and patients receive fluids and early low-fat enteral nutrition. During the study, participants undergo blood tests before treatment, and data including age, gender, medical history, medications, allergies, and family history are collected. Pain levels are monitored at 60 minutes, 6, 24, and 48 hours after treatment start. Researchers also track opioid use and length of hospital stay up to 14 days. Patients are observed for at least 48 hours after intervention to monitor treatment effects and any side effects.

Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children