[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594803":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":35,"locations":41,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":90,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Paracetamol + Iburprofen","EXPERIMENTAL","Group A will receive a dose of Paracetamol B. Braun\u002FParacetamol Kabi intravenously 15 mg\u002Fkg body weight (maximum 1000 mg\u002Fdose) and Ibuprofen B.Braun\u002FIbuprofen Kabi intravenously 10 mg\u002Fkg body weight (maximum 400 mg\u002Fdose).",[13,14,15],"Other: The initial pain assessment","Drug: Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)","Other: The effectiveness of the treatment",{"label":17,"type":10,"description":18,"interventionNames":19},"Paracetamol + Metamizol","Group B will receive a dose of Paracetamol B. Braun\u002FParacetamol Kabi intravenously 15 mg\u002Fkg body weight (maximum 1000 mg\u002Fdose) and Metamizol-SF\u002FMetamizole Kabi\u002FPyralgin intravenously 15 mg\u002Fkg body weight (maximum 100 mg\u002Fdose).",[13,14,15],[21,26,31],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"The initial pain assessment","The 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).",[9,17],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Drug administration according to protocol (paracetamol + ibuprofen OR paracetamol + metamizol)","Group A will receive a dose of Paracetamol B. Braun\u002FParacetamol Kabi intravenously 15 mg\u002Fkg body weight (maximum 1000 mg\u002Fdose) and Ibuprofen B.Braun\u002FIbuprofen Kabi intravenously 10 mg\u002Fkg body weight (maximum 400 mg\u002Fdose).\n\nGroup B will receive a dose of Paracetamol B. Braun\u002FParacetamol Kabi intravenously 15 mg\u002Fkg body weight (maximum 1000 mg\u002Fdose) and Metamizol-SF\u002FMetamizole Kabi\u002FPyralgin intravenously 15 mg\u002Fkg body weight (maximum 100 mg\u002Fdose).",[9,17],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"The effectiveness of the treatment","The 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).",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Aleksandra Banaszkiewicz, M.D., PhD","CONTACT","+48 22 317 9451","aleksandra.banaszkiewicz@wum.edu.pl",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Paediatric Gastroenterology and Nutrition","RECRUITING","Warsaw","02-091","Poland","PL",{"type":50,"coordinates":51},"Point",[52,53],21.01178,52.22977,{"lat":53,"lon":52},[56,59],{"name":57,"role":38,"phone":25,"phoneExt":25,"email":58},"Jan Bukowski, MD, PhD","bukowski.janek@gmail.com",{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Aleksandra Banaszkiewicz, MD PhD, Prof.","PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Aleksandra Banaszkiewicz","Prof. Aleksandra Banaszkiewicz, MD, PhD","100594803","phase-4-comparison-of-the-effectiveness-of-paracetamol-with-ibuprofen-or-paracetamol-with-metamizole-in-treating-pain-in-acute-pancreatitis-in-children-100594803",false,"NCT07024199","Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children","Comparison of the Effectiveness of Paracetamol With Ibuprofen or Paracetamol With Metamizole in Treating Pain in Acute Pancreatitis in Children: a Randomized Trial","Inclusion Criteria:\n\n* diagnosis of AP according to the INSPPIRE mentioned above criteria,\n* age from 3 to 18 years of age,\n* abdominal pain on admission assessed on the Numerical Rating Scale (NRS) or FLACC \\>= 4 points,\n* 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,\n* consent of legal guardians and the child (in the case of patients ≥16 years of age) to participate in the study.\n\nExclusion Criteria - patients:\n\n* who took the last dose of painkiller (paracetamol, ibuprofen, metamizole) \\\u003C 6 hours before entering the study,\n* allergic to acetylsalicylic acid, other NSAIDs, paracetamol, metamizole,\n* with inflammatory bowel disease,\n* with gastrointestinal bleeding and other active bleeding,\n* with gastric and\u002For duodenal ulcer disease,\n* chronically taking paracetamol, NSAIDs, metamizole,\n* with liver failure,\n* with heart failure according to the NYHA II-IV scale,\n* with acute and chronic renal failure,\n* with cancer,\n* whose legal guardians did not consent to participate in the study,\n* who did not consent to participate in the study (applies to patients \\> 16 years of age).","ALL","3 Years","18 Years",{"count":76,"type":77},78,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","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.",[83,84,85,86,87,88,89],"Pancreatitis, Acute","Pain, Acute","Pancreatic Disease","Pancreatic Diseases","Gastroenterology","Pancreatitis","Paediatrics",[91,92,93,94],"acute pancreatitis","acute pain","painkillers","pancreatitis","2025-08-18",{"date":97,"type":98},"2025-08-24","ACTUAL",{"date":100,"type":77},"2025-09",{"date":102,"type":77},"2027-06-01",{"name":5,"class":6},1]