[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655668":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":49,"studyPopulation":37,"armGroups":50,"interventions":63,"overallOfficials":70,"centralContacts":74,"locations":37,"responsibleParty":80,"collaborators":37,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":37,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":37,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":108,"whyStopped":37,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":37},{"fullName":5,"class":6},"Tehran University of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":37},[9],{"measure":10,"description":11,"timeFrame":12},"Pain score at 30 minutes","Numerical Rating Scale (NRS) for pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain (worse outcome)","30 minutes post-administration",[14,17,20,23,26,30,34],{"measure":15,"description":11,"timeFrame":16},"Pain score at 15 minutes","15 minutes post-administration",{"measure":18,"description":11,"timeFrame":19},"Pain score at 45 minutes","45 minutes post-administration",{"measure":21,"description":11,"timeFrame":22},"Pain score at 60 minutes","60 minutes post-administration",{"measure":24,"description":25,"timeFrame":12},"Need for rescue analgesia","IV morphine 0.1 mg\u002Fkg will be available at 30 minutes in cases of patients request",{"measure":27,"description":28,"timeFrame":29},"Side effects","The patients will be assessed every 15 minutes for this outcome","From the drug administration to 60 minutes afterward",{"measure":31,"description":32,"timeFrame":33},"Nasal irritation","Nasal irritation will be assessed using a 3-level Likert-like scale, ranging from 1 to 3, where 1 = no nasal irritation, 2 = mild nasal irritation, and 3 = severe nasal irritation. Higher scores indicate greater nasal irritation (worse outcome).","60 minutes after the drug administration",{"measure":35,"description":36,"timeFrame":33},"Patient satisfaction score","Patients will be asked to rate their satisfaction using a 5-level Likert-like scale, ranging from 1 to 5, where 1 = very dissatisfied and 5 = very satisfied. Higher scores indicate greater satisfaction (better outcome).",null,{"allocation":39,"interventionModel":40,"interventionModelDescription":37,"primaryPurpose":41,"observationalModel":37,"timePerspective":37,"maskingInfo":42},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":43,"maskingDescription":37,"whoMasked":44},"QUADRUPLE",[45,46,47,48],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Pain control is one of the problems in emergency departments (EDs). Analgesics in the intranasal (IN) form have been come into interest and focus because of their ease of application and effectiveness. Recently, IN ketorolac at 30mg has been turned out to have comparable efficacy with parenteral forms. Considering the ceiling effect of the ketorolac, this trial will study whether lower dose of 20mg for pain management is equally effective as 30mg dose.\n\nThe study is a multicenter, prospective, randomized, double blind, parallel group non inferiority clinical trial conducted in three EDs. Eligible participants are adults aged 18-65 years presenting with acute moderate to severe pain \\[numeric rating scale (NRS)≥4\\]. Participants will be randomized to receive atomized IN ketorolac 20 mg or 30 mg. Primary outcome is change in pain reduction at 30 minutes post administration. Secondary outcomes include pain reduction at 15, 45, and 60 minutes, requirement for rescue analgesia (IV morphine 0.1 mg\u002Fkg available at 30), gastrointestinal and other adverse effects, and patient satisfaction.",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"30mg Intranasal Ketorolac","ACTIVE_COMPARATOR","30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril",[56],"Drug: 30mg Intranasal Ketorolac",{"label":58,"type":59,"description":60,"interventionNames":61},"20mg intranasal ketorolac","EXPERIMENTAL","30 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril.",[62],"Drug: 20mg intranasal ketorolac",[64,68],{"type":65,"name":58,"description":66,"armGroupLabels":67,"otherNames":37},"DRUG","20 mg (1cc) ketorolac will be administered intranasally using mucosal atomizer. Half dose (0.5 cc) in each nostril",[58],{"type":65,"name":52,"description":54,"armGroupLabels":69,"otherNames":37},[52],[71],{"name":72,"affiliation":5,"role":73},"Hadi Mirfazaelian","PRINCIPAL_INVESTIGATOR",[75],{"name":76,"role":77,"phone":78,"phoneExt":37,"email":79},"Hadi Mirfazaelian, MD","CONTACT","00982161192240","h-mirfazaelian@sina.tums.ac.ir",{"type":73,"investigatorFullName":72,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Associate Professor","100655668","phase-3-atomized-intranasal-ketorolac-at-30-mg-versus-20-mg-for-the-treatment-of-acute-pain-in-the-emergency-department-a-randomized-non-inferiority-trial-100655668",false,"NCT07816302","Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department","Atomized Intranasal Ketorolac at 30 mg Versus 20 mg for the Treatment of Acute Pain in the Emergency Department: A Randomized Non-inferiority Trial","Inclusion Criteria:\n\n* Age: 18-65 years\n* Weight \\> 50 kg\n* Able to provide informed consent\n* Acute pain (\\\u003C48 hours) with verbally administered NRS≥4 (0-10 range, 0 = no - pain and 10 = worst imaginable pain)\n\nExclusion Criteria:\n\n* Active peptic ulcer disease (PUD)\n* History of hypersensitivity to NSAIDs\n* Pregnancy and breastfeeding\n* Renal failure\n* Hepatic failure\n* Patients who have received analgesics within the past 6 hours\n* Nasal congestion\n* Upper respiratory tract infection\n* Patients with a history of kidney transplantation\n* Active gastrointestinal bleeding\n* Systolic blood pressure less than 90 mmHg or greater than 180 mmHg\n* Heart rate less than 50 per minute or greater than 150 per minute\n* Concurrent use of NSAIDs or anticoagulant drugs\n* Inability to provide informed consent\n* Anatomical abnormalities of the nose or skull base (congenital or acquired)\n* Hyperreactive airway disease such as severe asthma\n* Coagulation disorders\n* Intracranial hemorrhage\n* Suspected aortic dissection\n* Suspected rupture of abdominal aortic aneurysm\n* History of gastrointestinal perforation\n* Gastrointestinal bleeding within the past month\n* Chronic pain disorders\n* Substance misuse\n* Immediate opioid necessity\n* Altered mental status\n* Any pain that is considered to be not appropriate for receiving NSAIDS by emergency physician","ALL","18 Years","65 Years",{"count":93,"type":94},100,"ESTIMATED","INTERVENTIONAL",[97],"PHASE3","This study aims to compare the analgesic effectiveness and side effects of intranasal ketorolac at 30 mg Versus 20 mg for the Treatment of Acute moderate and severe Pain in the Emergency Department.",[100,101,102],"Pain","Ketorolac","Intranasal Drug Administration",[104,105,106,107,101],"Emergency department","pain","intranasal","ceiling effect","NOT_YET_RECRUITING","2026-09-11",{"date":111,"type":112},"2026-09-16","ACTUAL",{"date":114,"type":94},"2026-10-10",{"date":116,"type":94},"2027-05-01",{"name":5,"class":6}]