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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age3-18
SponsorMedical University of Warsaw

About this trial

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.

Eligibility criteria

Qualifiers

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,

Disqualifiers

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,

Trial design

Treatments tested in this trial

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

Treatment groups

78 Participants
are divided into 2 treatment groups

Sponsors and collaborators