[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542657":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":42,"centralContacts":47,"locations":56,"responsibleParty":74,"collaborators":51,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":51,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":59,"whyStopped":51,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Monastir","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Paracétamol-tramadol","EXPERIMENTAL","Each patient received 1 tablet \\* 2\u002Fday synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days.",[13],"Drug: paracétamol tramadol",{"label":15,"type":10,"description":16,"interventionNames":17},"Paracetamol-caffeine","Each patient received 1 tab \\* 3\u002Fd stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days",[18],"Drug: Paracétamol cafeine",{"label":20,"type":10,"description":21,"interventionNames":22},"Placebo","Each patient received 1 tab \\* 3 \u002F d of placebo (flour) every day for 7 days.\n\n\\*For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding.",[23],"Drug: Placebo",[25,32,37],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","paracétamol tramadol","Each patient received 1 tablet \\* 2\u002Fday synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days",[9],[31],"B",{"type":26,"name":33,"description":16,"armGroupLabels":34,"otherNames":35},"Paracétamol cafeine",[15],[36],"A",{"type":26,"name":20,"description":38,"armGroupLabels":39,"otherNames":40},"Each patient received 1 tab \\* 3 \u002F d of placebo (flour) every day for 7 days",[20],[41],"C",[43],{"name":44,"affiliation":45,"role":46},"Khaoula Bel Haj Ali","CHU Fattouma Bourguiba Monastir, service des urgences","STUDY_DIRECTOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","99792724",null,"belhajalikhaoula@yahoo.fr",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":51},"Semir Nouira, Pr","21673106046",[57],{"facility":58,"status":59,"city":60,"state":51,"zip":51,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Semir Nouira","RECRUITING","Monastir","Tunisia","TN",{"type":64,"coordinates":65},"Point",[66,67],10.82617,35.77799,{"lat":67,"lon":66},[70],{"name":71,"role":49,"phone":72,"phoneExt":51,"email":73},"semir nouirq, professor","0021673106046","semir.nouira.urg@gmail.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"PRINCIPAL_INVESTIGATOR","Pr. Semir Nouira","PROFESSOR","100542657","phase-2-paracetamol-tramadol-and-paracetamol-caffeine-versus-placebo-in-the-emergency-discharge-treatment-of-renal-colic-100542657",false,"NCT06345716","Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic","RC","Inclusion Criteria:\n\n* -Age \\> 18 years old.\n* Consent to participate in the study.\n* Pain in the flank\u002Flumbar fossa of sudden onset with urine strips and\u002For imaging corresponding to the diagnosis of renal colic.\n* Pain score at discharge \\\u003C 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).\n\nExclusion Criteria:\n\n* -Inability to appreciate pain according to the VAS.\n* Pregnant or breastfeeding woman.\n* Renal insufficiency with creatinine clearance \\\u003C 60 ml\u002Fmin.","ALL","18 Years","99 Years",{"count":89,"type":90},1500,"ESTIMATED","INTERVENTIONAL",[93],"PHASE2","This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.",[96],"Renal Colic",[98,99,100,101],"renal colic","paracetamol-tramadol","paracetamol-cafeine","placebo","2024-09-11",{"date":104,"type":105},"2024-09-19","ACTUAL",{"date":107,"type":105},"2024-04-10",{"date":109,"type":90},"2025-11-30",{"name":5,"class":6},1]