Actively Recruiting
Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
Led by Medical University of Warsaw · Updated on 2025-08-24
78
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effectiveness and tolerance of two pain treatments for acute pancreatitis in children aged 3 to 18 years. The study is prospective, interventional, randomized, and sponsored by the Medical University of Warsaw. Children diagnosed with acute pancreatitis based on INSPPIRE criteria and experiencing significant abdominal pain are enrolled to assess which combination provides better pain relief. Participants are randomly assigned to one of two treatment groups. Group A receives intravenous paracetamol at 15 mg/kg (up to 1000 mg) combined with ibuprofen at 10 mg/kg (up to 400 mg). Group B receives intravenous paracetamol at the same dose combined with metamizole at 15 mg/kg (up to 100 mg). Pain is assessed before treatment and again 60 minutes after administration using age-appropriate pain scales such as NRS and FLACC. After treatment, pain management continues at the physician's discretion, and patients receive fluids and early low-fat enteral nutrition. During the study, participants undergo blood tests before treatment, and data including age, gender, medical history, medications, allergies, and family history are collected. Pain levels are monitored at 60 minutes, 6, 24, and 48 hours after treatment start. Researchers also track opioid use and length of hospital stay up to 14 days. Patients are observed for at least 48 hours after intervention to monitor treatment effects and any side effects.
CONDITIONS
Brief Title
Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute pancreatitis according to INSPPIRE criteria
- Age between 3 and 18 years
- Abdominal pain on admission with a score of 4 or higher on the Numerical Rating Scale (NRS) or FLACC scale
- No analgesic treatment before enrollment or last dose of paracetamol, ibuprofen, or metamizole taken at least 6 hours before enrollment
- Consent from legal guardians and the child if 16 years or older
You will not qualify if you...
- Painkiller taken less than 6 hours before entering the study
- Allergy to acetylsalicylic acid, NSAIDs, paracetamol, or metamizole
- Inflammatory bowel disease
- Gastrointestinal bleeding or other active bleeding
- Gastric or duodenal ulcer disease
- Chronic use of paracetamol, NSAIDs, or metamizole
- Liver failure
- Heart failure classified as NYHA II-IV
- Acute or chronic renal failure
- Cancer
- Lack of consent to participate from legal guardians or the patient if older than 16 years
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants receive treatment with one of two drug regimens: paracetamol with ibuprofen or paracetamol with metamizole administered intravenously. Pain assessments are conducted before treatment, 60 minutes after treatment start, and at 6, 24, and 48 hours to evaluate effectiveness. Participants are observed for 48 hours from the start of the intervention.
Initial treatment visit plus assessments at 60 minutes, 6, 24, and 48 hours
Trial Site Locations
Total: 1 location
1
Department of Paediatric Gastroenterology and Nutrition
Warsaw, Poland, 02-091
Actively Recruiting
Research Team
A
Aleksandra Banaszkiewicz, M.D., PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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