Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-02-18 @ 1:35 AM
Study NCT ID:
NCT01891435
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005334', 'term': 'Fever'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 434}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-28', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-06-28', 'lastUpdatePostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in temperature in every thirty minutes till 120 minutes after receiving antipyretics', 'timeFrame': 'Reduction in temperature is checked every 30 minutes for a maximum of 120 minutes', 'description': 'Once the patients fulfill the inclusion criteria, they are randomly assigned to receive one of the three medications in the study ( oral paracetamol, intravenous paracetamol or intramuscular diclofenac). Baseline temperature is recorded using a standard thermometer. Then reduction in temperature is recorded every 30 minutes for 2 hours.'}]}, 'conditionsModule': {'keywords': ['antipyretics', 'oral paracetamol', 'intravenous paracetamol', 'intramuscular diclofenac', 'emergency department'], 'conditions': ['Fever', 'Reduction in Temperature']}, 'descriptionModule': {'briefSummary': 'A randomized clinical trial to check the antipyretic efficacy of oral and intravenous paracetamol and intramuscular diclofenac sodium in patients presenting with fever to emergency department.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between the age of 14-75 years with an oral temperature of more than 38.5 C\n\nExclusion Criteria:\n\n* History of allergy to any of the drugs in the study\n* Had taken antipyretics within 8 hours\n* Renal, hepatic or haematological disorders\n* bronchial asthma, peptic ulcer disease, vomiting\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT01891435', 'briefTitle': 'The Antipyretic Efficacy of Oral and Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hamad Medical Corporation'}, 'officialTitle': 'A Randomized Controlled Clinical Trial on the Antipyretic Efficacy of Oral Paracetamol, Intravenous Paracetamol and Intramuscular Diclofenac in Patients Presenting With Fever to Emergency Department', 'orgStudyIdInfo': {'id': '9070/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oral paracetamol', 'description': 'patients in this arm will receive 1000mg of oral paracetamol', 'interventionNames': ['Drug: Oral paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous paracetamol', 'description': 'patients in this arm will receive 1000 mg of intravenous paracetamol', 'interventionNames': ['Drug: Intravenous paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular Diclofenac', 'description': 'patients in this arm will receive 75 mg of intramuscular diclofenac sodium', 'interventionNames': ['Drug: Intramuscular diclofenac']}], 'interventions': [{'name': 'Oral paracetamol', 'type': 'DRUG', 'description': 'after giving medicine temperature is checked every 30 minutes for 2 hours', 'armGroupLabels': ['oral paracetamol']}, {'name': 'Intravenous paracetamol', 'type': 'DRUG', 'description': 'after giving medicine temperature is checked every 30 minutes for 2 hours', 'armGroupLabels': ['Intravenous paracetamol']}, {'name': 'Intramuscular diclofenac', 'type': 'DRUG', 'description': 'after giving medicine temperature is checked every 30 minutes for 2 hours', 'armGroupLabels': ['Intramuscular Diclofenac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Doha', 'country': 'Qatar', 'facility': 'Hamad medical corporation', 'geoPoint': {'lat': 25.28545, 'lon': 51.53096}}], 'overallOfficials': [{'name': 'osama H Mohammed', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamad Medical Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamad Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist, Emergency Department', 'investigatorFullName': 'Firjeeth C Paramba', 'investigatorAffiliation': 'Hamad Medical Corporation'}}}}