Paracetamol with ibuprofen versus paracetamol with metamizole for pain in children with acute pancreatitis
Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
We will test whether IV paracetamol combined with ibuprofen or IV paracetamol combined with metamizole reduces pain more effectively in children aged 3–18 with acute pancreatitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 3 Years to 18 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT07024199 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Children aged 3–18 years with acute pancreatitis, presenting with moderate-to-severe abdominal pain (NRS or FLACC ≥4), not having received analgesics in the prior 6 hours, and with guardian (and patient if ≥16) consent are eligible.
Not a fit: Children who have taken an analgesic within 6 hours, have allergies to NSAIDs/paracetamol/metamizole, inflammatory bowel disease, active gastrointestinal bleeding, peptic ulcer disease, chronic analgesic use, liver failure, or significant heart failure are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the regimen shown to work better could offer faster, better-tolerated pain relief for children with acute pancreatitis and may reduce need for stronger opioids.
How similar studies have performed: While combinations of paracetamol with NSAIDs or metamizole are used in practice, direct randomized comparisons specifically in pediatric acute pancreatitis are limited, so this head-to-head comparison is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Warsaw
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.