00061838

00061838

To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. To 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.

2013-08-01

2016-11-01

2016-11-01

Completed

Early phase I

210

Inclusion Criteria: * \> 45 kg (amenable to adult dosing) * all traumatic brain injuries NPO for at least 12 hours * all post-operative craniotomy patients * all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients * all carotid endarterectomy and carotid artery stenosis patients * all endovascular patients undergoing intracranial intervention * all post-op spine patients admitted to the NCCU Exclusion Criteria: * documented allergy to acetaminophen * documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis) * 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. * patients who are pregnant or breast feeding

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 210, 'type': 'ACTUAL'}}

2023-04-24