Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT01948505
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2013-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'walavan.sivakumar@gmail.com', 'phone': '424-212-5361', 'title': 'Dr. Walavan Sivakumar', 'organization': 'Pacific Neuroscience Institute'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Caveats, a maximum of 3 g of IV acetaminophen was used to minimize the chance for acetaminophen-related toxicity and comply with current dosage recommendations of our university pharmacy.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Experimental Group', 'description': 'IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nIntravenous acetaminophen', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nPlacebo for IV acetaminophen', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Narcotic Requirement After Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nIntravenous acetaminophen'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nPlacebo for IV acetaminophen'}], 'classes': [{'categories': [{'measurements': [{'value': '123.5', 'groupId': 'OG000', 'lowerLimit': '102.9', 'upperLimit': '144.2'}, {'value': '134.2', 'groupId': 'OG001', 'lowerLimit': '112.1', 'upperLimit': '156.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.', 'unitOfMeasure': 'Morphine Equivalents', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Frequency of Nausea, Vomiting, Urinary Retention & Constipation', 'timeFrame': '48 hours', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group', 'description': 'IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nIntravenous acetaminophen'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nPlacebo for IV acetaminophen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '105'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group', 'description': 'IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nIntravenous acetaminophen'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication\n\nPlacebo for IV acetaminophen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'BG000', 'lowerLimit': '47.6', 'upperLimit': '53.5'}, {'value': '50.3', 'groupId': 'BG001', 'lowerLimit': '47.4', 'upperLimit': '53.2'}, {'value': '50.5', 'groupId': 'BG002', 'lowerLimit': '47.5', 'upperLimit': '53.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2013-09-18', 'resultsFirstSubmitDate': '2018-05-07', 'studyFirstSubmitQcDate': '2013-09-20', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-20', 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Frequency of Nausea, Vomiting, Urinary Retention & Constipation', 'timeFrame': '48 hours'}], 'primaryOutcomes': [{'measure': 'Narcotic Requirement After Surgery', 'timeFrame': '48 hours', 'description': 'The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Craniotomy'], 'conditions': ['Post-operative Craniotomy Patients', 'Carotid Endarterectomy and Carotid Artery Stenosis Patients', 'Post-op Spine Patients Admitted to the NCCU', 'Endovascular Patients Undergoing Intracranial Intervention', 'Traumatic Brain Injuries NPO for at Least 12 Hours']}, 'referencesModule': {'references': [{'pmid': '29676689', 'type': 'DERIVED', 'citation': 'Sivakumar W, Jensen M, Martinez J, Tanana M, Duncan N, Hoesch R, Riva-Cambrin JK, Kilburg C, Ansari S, House PA. Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial. J Neurosurg. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.'}]}, 'descriptionModule': {'briefSummary': 'To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain.\n\nTo assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients.\n\nTo assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 45 kg (amenable to adult dosing)\n* all traumatic brain injuries NPO for at least 12 hours\n* all post-operative craniotomy patients\n* all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients\n* all carotid endarterectomy and carotid artery stenosis patients\n* all endovascular patients undergoing intracranial intervention\n* all post-op spine patients admitted to the NCCU\n\nExclusion Criteria:\n\n* documented allergy to acetaminophen\n* documented severe hepatic impairment (Child-Pugh score \\> 6) or severe hepatic disease (hepatitis)\n* documented severe renal impairment (CrCl \\< 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.\n* patients who are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01948505', 'briefTitle': 'Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'orgStudyIdInfo': {'id': '00061838'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication', 'interventionNames': ['Drug: Intravenous acetaminophen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication', 'interventionNames': ['Drug: Placebo for IV acetaminophen']}], 'interventions': [{'name': 'Intravenous acetaminophen', 'type': 'DRUG', 'armGroupLabels': ['Intervention group']}, {'name': 'Placebo for IV acetaminophen', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}