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

NCT07024199 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-08-24

No results posted yet for this study

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.

Conditions

Interventions

OTHER

The initial pain assessment

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).

DRUG

Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)

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).

OTHER

The effectiveness of the treatment

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).

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07024199 on ClinicalTrials.gov