Clinical trial NCT07024199: Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children
Official title: Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pancreatitis, Acute
Pain, Acute
Pancreatic Disease
Pancreatic Diseases
Gastroenterology
Pancreatitis
Paediatrics
Keywords: acute pancreatitis
acute pain
painkillers
pancreatitis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 78
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients with AP diagnosed based on the INSPIRE criteria who meet the inclusion as mentioned above criteria for the study will be randomized (based on a computer-generated randomization list, in blocks of four people) to treatment with one of two regimens:

Group A will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and ibuprofen 10 mg/kg body weight (maximum 400 mg/dose).

Group B will receive a dose of paracetamol intravenously 15 mg/kg body weight (maximum 1000 mg/dose) and metamizole 15 mg/kg body weight (maximum 100 mg/dose).

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, Wong-Baker Faces Scale/FLACC- attached). The effectiveness of the treatment will be assessed 60 minutes after the start of the intervention.

Before starting the intervention, all patients during obtaining peripheral intravenous access will undergo a panel of laboratory tests including: alanine aminotransferase, aspartate aminotransferase and gamma-glutamyltransferase activity, total, conjugated and unconjugated bilirubin level, peripheral blood morphology, C-reactive protein, glucose, creatinine, calcium, albumin and urea nitrogen level. Oral and/or intravenous fluid supply in the range of 1.5 to 2 times the daily requirement will be provided, as well as early low-fat enteral nutrition.

After the intervention is completed, the decision on further analgesic treatment will remain at the discretion of the attending physician.

In addition, during the examination, data about the patient will be collected, such as: age, gender, body weight, height, history of chronic diseases and congenital defects, medications taken, reported allergies and family history, with particular emphasis on pancreatic diseases, as well as the results of laboratory tests and imaging, as well as data on possible side effects of the treatment. The patient will be observed for 48 hours from the start of the intervention.

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 NRS or Wong-Baker Faces Scale/FLACC scale, as mild or moderate (less than 8 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).

Primary outcomes:
measure: Reduction in pain intensity assessed at the 60th minute of the examination using ONE of the SCALES.
timeFrame: at the 60th minute after introduction of the intervention
Secondary outcomes:
measure: Length of hospitalization.
timeFrame: at the time of discharge (up to 14 days)
measure: Consumption of opioid drugs.
timeFrame: at the 48th hour after introduction of the intervention
measure: Reduction in pain intensity assessed at the 6th, 24th and 48th hour.
timeFrame: at 6th, 24th and 48th hour after introduction of the intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Paediatric Gastroenterology and Nutrition
Study officials:
References: