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

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.