Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention group

IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Group Type ACTIVE_COMPARATOR

Intravenous acetaminophen

Intervention Type DRUG

Placebo Group

IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Group Type PLACEBO_COMPARATOR

Placebo for IV acetaminophen

Intervention Type DRUG

Interventions

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Intravenous acetaminophen

Intervention Type DRUG

Placebo for IV acetaminophen

Intervention Type DRUG

Other Intervention Names

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Normal Saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No