Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
Medical University of Warsaw
78 participants
Sep 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria12
- 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).
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Interventions
The initial pain assessment will be carried out according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC).
Group A will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Ibuprofen B.Braun/Ibuprofen Kabi intravenously 10 mg/kg body weight (maximum 400 mg/dose). Group B will receive a dose of Paracetamol B. Braun/Paracetamol Kabi intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and Metamizol-SF/Metamizole Kabi/Pyralgin intravenously 15 mg/kg body weight (maximum 100 mg/dose).
The effectiveness of the treatment will be assessed 60 minutes after the start of the intervention according to pain assessment scales in children adapted to the patient's age and cognitive abilities (NRS, FLACC).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07024199