Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Phase 4CompletedNCT01948505

University of Utah210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

210

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Narcotic Requirement After Surgery

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.

Time frame: 48 hours