Paracetamol with ibuprofen versus paracetamol with metamizole for pain in children with acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized trial that assigns children with acute pancreatitis to one of two IV analgesic regimens: paracetamol (15 mg/kg, max 1000 mg) plus ibuprofen (10 mg/kg, max 400 mg) or paracetamol (15 mg/kg, max 1000 mg) plus metamizole (15 mg/kg, max 100 mg). Pain is assessed using age-appropriate scales (NRS, Wong-Baker Faces, or FLACC) before treatment and again 60 minutes after the intervention to measure immediate effectiveness. Standard baseline labs and supportive care including fluids and early low-fat enteral nutrition are provided to all participants. Randomization is computer-generated in blocks of four and the trial targets patients meeting INSPPIRE diagnostic criteria for pediatric acute pancreatitis.

Why it matters

Who can join: the full rules

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 Numerical Rating Scale (NRS) or FLACC \>= 4 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).

Where it's running

• Department of Paediatric Gastroenterology and Nutrition
  Warsaw, Poland Recruiting

Study contacts

• Study coordinator: Aleksandra Banaszkiewicz, M.D., PhD
• Email: aleksandra.banaszkiewicz@wum.edu.pl
• Phone: +48 22 317 9451

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.