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

NCT07024199 | Recruiting Phase 4

• 1 other identifier: APPain
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis, Acute; Pain, Acute; Pancreatic Disease; Pancreatic Diseases; Gastroenterology; Pancreatitis; Paediatrics

Keywords

acute pancreatitis; acute pain; painkillers; pancreatitis

Outcome Measures

Primary Outcomes (1)

• Reduction in pain intensity assessed at the 60th minute of the examination using ONE of the SCALES.

  The number of patients who observed a reduction in pain intensity of \<4 points on the NRS scale (for children from 7 years of age) or FLACC scale (for children from 3 to 7 years of age) in both study groups, assessed at the 60th minute of the study. NRS is used to assess pain severity at a given moment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable." The FLACC scale \[Face, Legs, Activity, Cry, Consolability\] is used to assess pain between the ages of 2 months and 7 years or in individuals who are unable to communicate their pain. The scale is scored in a range of 0-10, with 0 representing no pain. The scale has 5 criteria, which are each assigned a score of 0, 1 or 2.

  at the 60th minute after introduction of the intervention

Secondary Outcomes (3)

• Length of hospitalization.

  at the time of discharge (up to 14 days)

• Consumption of opioid drugs.

  at the 48th hour after introduction of the intervention

• Reduction in pain intensity assessed at the 6th, 24th and 48th hour.

  at 6th, 24th and 48th hour after introduction of the intervention

Study Arms (2)

Paracetamol + Iburprofen

EXPERIMENTAL

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).

Other: The initial pain assessment; Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol); Other: The effectiveness of the treatment

Paracetamol + Metamizol

EXPERIMENTAL

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 initial pain assessment; Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol); Other: The effectiveness of the treatment

Interventions

The initial pain assessment OTHER

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).

Paracetamol + Iburprofen; Paracetamol + Metamizol

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

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).

Paracetamol + Iburprofen; Paracetamol + Metamizol

The effectiveness of the treatment OTHER

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).

Paracetamol + Iburprofen; Paracetamol + Metamizol

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Paediatric Gastroenterology and Nutrition

Warsaw, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Acute Pain; Pancreatic Diseases

Interventions

Acetaminophen; Ibuprofen; Dipyrone

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Aminopyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Aleksandra Banaszkiewicz, M.D., PhD

CONTACT

+48 22 317 9451; aleksandra.banaszkiewicz@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Aleksandra Banaszkiewicz, MD, PhD

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: June 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

PL (1)