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.
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,
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,
Parallel
The initial pain assessment
Other interventionThe 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).
Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)
DrugGroup 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).
The effectiveness of the treatment
Other interventionThe 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).
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.
Length of hospitalization.
Length of hospitalization in both study groups.
Consumption of opioid drugs.
Consumption of opioid drugs within 48 hours from the start of the study calculated per morphine equivalent/kg body weight.
Reduction in pain intensity assessed at the 6th, 24th and 48th hour.
The number of patients who observed a reduction in pain intensity by at least 2 points on the NRS scale (for children aged 7 years and over) or FLACC scale (for children aged 3 to 7 years) in both study groups, assessed at 6, 24, and 48 hours 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.
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