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

RecruitingPhase 4Ages 3 Years - 18 YearsAllMedical University of Warsaw
NCT07024199 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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).
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What it tests

  • The initial pain assessment
  • Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)
  • The effectiveness of the treatment
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Where

1 site
Department of Paediatric Gastroenterology and Nutrition
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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