Effectiveness of intravenous paracetamol plus ibuprofen versus intravenous paracetamol plus metamizole for pain in children with acute pancreatitis at tertiary referral centres in Poland: a multicentre randomised controlled trial protocol
- 1Department of Paediatric Gastroenterology and Nutrition, Medical University of Warsaw, Warsaw, Masovian Voivodeship, Poland
Abstract
Introduction Acute pancreatitis (AP) is an acute inflammatory process characterised by premature activation of pancreatic proenzymes leading to pancreatic parenchymal injury and, in some cases, distant organ involvement. The incidence of AP in children has risen significantly over recent decades, reaching approximately 13 cases per 100 000 children per year in Europe, with idiopathic aetiologies being the most common. Effective pain management is central to AP treatment, yet high-quality evidence on analgesic strategies in the paediatric population is lacking. The aim of the study is to assess the effectiveness and tolerance of pain treatment in paediatric AP using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole.Methods and analysis In this prospective, multicentre, randomised interventional study, children aged 3–18 years with AP defined by the INternational Study Group of Pediatric Pancreatitis: In search for a cuRE (INSPPIRE) criteria and moderate to severe abdominal pain will be allocated in a 1:1 ratio to receive intravenous paracetamol combined with either ibuprofen or metamizole. Pain intensity will be measured at baseline using validated, age-appropriate scales (Numerical Rating Scale or Face, Legs, Activity, Cry, Consolability). The primary outcome is the proportion of participants achieving a pain score below 4 points 60 min after treatment initiation. Secondary outcomes include length of hospital stay, opioid use within 48 hours expressed as morphine milligram equivalents per kilogram, and changes in pain intensity at 6, 24 and 48 hours. Analyses will be conducted on a per-protocol basis using appropriate parametric or non-parametric methods.Ethics and dissemination The study has been approved by the Ethics Committee of the Medical University of Warsaw, Poland (protocol version: 5 August 2025, KB/45/A/2025). Study findings will be disseminated through peer-reviewed publications and scientific conferences.Trial registration number NCT07024199.
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BibTeX
@article{warchol2026effectiveness,
title = {{Effectiveness of intravenous paracetamol plus ibuprofen versus intravenous paracetamol plus metamizole for pain in children with acute pancreatitis at tertiary referral centres in Poland: a multicentre randomised controlled trial protocol}},
author = {Aleksandra Anna Warchoł and Jan Stanisław Bukowski and Aleksandra Banaszkiewicz},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2026-118871},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118871},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Effectiveness of intravenous paracetamol plus ibuprofen versus intravenous paracetamol plus metamizole for pain in children with acute pancreatitis at tertiary referral centres in Poland: a multicentre randomised controlled trial protocol
AU - Aleksandra Anna Warchoł
AU - Jan Stanisław Bukowski
AU - Aleksandra Banaszkiewicz
PY - 2026
DA - 2026/10/23
JO - BMJ Open
DO - 10.1136/bmjopen-2026-118871
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-118871
AB - Introduction Acute pancreatitis (AP) is an acute inflammatory process characterised by premature activation of pancreatic proenzymes leading to pancreatic parenchymal injury and, in some cases, distant organ involvement. The incidence of AP in children has risen significantly over recent decades, reaching approximately 13 cases per 100 000 children per year in Europe, with idiopathic aetiologies being the most common. Effective pain management is central to AP treatment, yet high-quality evidence on analgesic strategies in the paediatric population is lacking. The aim of the study is to assess the effectiveness and tolerance of pain treatment in paediatric AP using intravenous paracetamol in combination with ibuprofen or paracetamol in combination with metamizole.Methods and analysis In this prospective, multicentre, randomised interventional study, children aged 3–18 years with AP defined by the INternational Study Group of Pediatric Pancreatitis: In search for a cuRE (INSPPIRE) criteria and moderate to severe abdominal pain will be allocated in a 1:1 ratio to receive intravenous paracetamol combined with either ibuprofen or metamizole. Pain intensity will be measured at baseline using validated, age-appropriate scales (Numerical Rating Scale or Face, Legs, Activity, Cry, Consolability). The primary outcome is the proportion of participants achieving a pain score below 4 points 60 min after treatment initiation. Secondary outcomes include length of hospital stay, opioid use within 48 hours expressed as morphine milligram equivalents per kilogram, and changes in pain intensity at 6, 24 and 48 hours. Analyses will be conducted on a per-protocol basis using appropriate parametric or non-parametric methods.Ethics and dissemination The study has been approved by the Ethics Committee of the Medical University of Warsaw, Poland (protocol version: 5 August 2025, KB/45/A/2025). Study findings will be disseminated through peer-reviewed publications and scientific conferences.Trial registration number NCT07024199.
SN - 2044-6055
SN - 2044-6055
ER -