No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
3 – 18
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
78 (estimated)
Sponsor
Medical University of Warsaw · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 ana…
Inclusion Criteria:
* 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.
Exclusion Criteria - patients:
* 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).
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