Phase 4
N=210
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
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
Bottom Line
View on ClinicalTrials.gov: NCT01948505 ↗Enrolled (actual)
210
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Narcotic Requirement After Surgery — 123.5; 134.2 Morphine Equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Intravenous acetaminophen (Drug); Placebo for IV acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Requirement After Surgery |
123.5; 134.2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01948505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.