Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
Department of Paediatric Gastroenterology and Nutrition
RECRUITING
Warsaw
Contact Information
Primary
Aleksandra Banaszkiewicz, M.D., PhD
aleksandra.banaszkiewicz@wum.edu.pl
+48 22 317 9451
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 78
Treatments
Experimental: Paracetamol + Iburprofen
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).
Experimental: Paracetamol + Metamizol
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).
Sponsors
Leads: Medical University of Warsaw

This content was sourced from clinicaltrials.gov