NCT07024199 Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
| NCT ID | NCT07024199 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Medical University of Warsaw |
| Condition | Pancreatitis, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-09 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2025-09 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07024199 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07024199 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07024199 currently recruiting?
Yes, NCT07024199 is actively recruiting participants. Contact the research team at aleksandra.banaszkiewicz@wum.edu.pl for enrollment information.
Where is the NCT07024199 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT07024199 clinical trial?
NCT07024199 is sponsored by Medical University of Warsaw. The trial plans to enroll 78 participants.