Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
Recruiting now · Phase 4
Conditions studied: Pancreatitis, Acute, Pain, Acute, Pancreatic Disease, Pancreatic Diseases, Gastroenterology, Pancreatitis, Paediatrics
In brief
The aim of the study is to assess the effectiveness and tolerance of pain treatment in AP in children using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole. The study is prospective, interventional, and randomized.
Key facts
- Study ID
- NCT07024199
- Run by
- Medical University of Warsaw
- People needed
- 78
- Starts
- 2025-09-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-08-24
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 is running
- Department of Paediatric Gastroenterology and Nutrition — Warsaw, Poland (enrolling)
Full record on ClinicalTrials.gov
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