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

Launched by MEDICAL UNIVERSITY OF WARSAW · Jun 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well two different combinations of pain medicines work to treat children who have sudden inflammation of the pancreas, a condition called acute pancreatitis. The researchers want to see if using paracetamol (a common pain reliever) with either ibuprofen or metamizole (another pain medicine) helps reduce pain and is safe for children. They will compare these two treatment options to find out which one works better for managing pain in kids with this condition.

Children between the ages of 3 and 18 who have been diagnosed with acute pancreatitis and are experiencing mild to moderate belly pain may be able to join the study. To be eligible, the child should not have taken any pain medicine for at least six hours before starting the trial. Parents or guardians, and the child if they are 16 or older, must agree to participate. During the study, children will receive one of the two medicine combinations through a vein (intravenously), and doctors will monitor how well the pain is controlled and watch for any side effects. Children with certain health issues, like allergies to these medicines, ongoing bleeding, serious liver or kidney problems, or cancer, are not eligible to join. This study is currently recruiting participants and aims to help doctors find the safest and most effective way to relieve pain in children with acute pancreatitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • diagnosis of AP according to the INSPPIRE mentioned above criteria,
• • age from 3 to 18 years of age,
• • abdominal pain on admission assessed on the NRS or Wong-Baker Faces Scale/FLACC scale, as mild or moderate (less than 8 points),
• • no analgesic treatment before enrolment in the study OR the last dose of analgesic drug (paracetamol, ibuprofen, metamizole) taken ≥ 6 hours before enrolment for examination,
• • consent of legal guardians and the child (in the case of patients ≥16 years of age) to participate in the study.
• Exclusion Criteria - patients:
• • who took the last dose of painkiller (paracetamol, ibuprofen, metamizole) \< 6 hours before entering the study,
• • allergic to acetylsalicylic acid, other NSAIDs, paracetamol, metamizole,
• • with inflammatory bowel disease,
• • with gastrointestinal bleeding and other active bleeding,
• • with gastric and/or duodenal ulcer disease,
• • chronically taking paracetamol, NSAIDs, metamizole,
• • with liver failure,
• • with heart failure according to the NYHA II-IV scale,
• • with acute and chronic renal failure,
• • with cancer,
• • whose legal guardians did not consent to participate in the study,
• • who did not consent to participate in the study (applies to patients \> 16 years of age).