Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02897856
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2016-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2016-09-04', 'studyFirstSubmitQcDate': '2016-09-07', 'lastUpdatePostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cessation of seizure activity five minutes after treatment with study medication.', 'timeFrame': 'five minutes', 'description': 'Cessation of abnormal motor activity with regaining of consciousness.'}], 'secondaryOutcomes': [{'measure': 'Major side effects.', 'timeFrame': '2 hours after cessation of seizures.'}, {'measure': 'Duration of seizure.', 'timeFrame': '5 minutes'}, {'measure': 'Recurrence of seizure activity within one hour after treatment with study medication.', 'timeFrame': 'one hour'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seizures']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to prove that intramuscular midazolam is more effective than buccal midazolam in cessation of seizure activity with comparable side effects.', 'detailedDescription': 'Both buccal and intramuscular midazolam have been used to control seizures with variable succuss rates and side effects.\n\nIn this study the investigators are going to assign patient randomly to receive either buccal or intramuscular midazolam. Then will compare both efficacy and side effect in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children 6 month to 14 years who will be presented to the pediatric emergency or attended by emergency medical service who have active seizure and had no intravenous access would be eligible for the study.\n\nExclusion Criteria:\n\n* Cardiac arrest\n* Head trauma\n* Drowning\n* Congenital heart disease\n* Inborn errors of metabolism\n* Electrolyte imbalance (hypocalcaemia, hyponatremia and hypoglycemia)\n* Hemodynamic instability\n* Allergy to benzodiazepines\n* Focal seizures with preserved level of consciousness'}, 'identificationModule': {'nctId': 'NCT02897856', 'briefTitle': 'Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'Efficacy and Safety of Intramuscular Midazolam Compared to Buccal Midazolam in Pediatric Seizures: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '14-00050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Buccal midazolam', 'description': 'Study subject will receive buccal midazolam and intramuscular placebo. The dose of buccal midazolam is 0.3 mg/kg', 'interventionNames': ['Drug: Buccal midazolam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intramuscular midazolam', 'description': 'Study subject will receive intramuscular midazolam and buccal placebo. The dose of intramuscular midazolam is 0.25 mg/kg.', 'interventionNames': ['Drug: Intramuscular midazolam']}], 'interventions': [{'name': 'Buccal midazolam', 'type': 'DRUG', 'description': 'Study subject will receive Buccal midazolam, Intramuscular placebo.', 'armGroupLabels': ['Buccal midazolam']}, {'name': 'Intramuscular midazolam', 'type': 'DRUG', 'description': 'Study subject will receive Intramuscular midazolam,Buccal placebo', 'armGroupLabels': ['intramuscular midazolam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Doha', 'country': 'Qatar', 'facility': 'Hamad medical corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior consultanat', 'investigatorFullName': 'DR. KHALID AL-ANSARI', 'investigatorAffiliation': 'Hamad Medical Corporation'}}}}