The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-01

Study Completion Date

2017-11-01

Brief Summary

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The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Acetaminophen First

Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive acetaminophen first.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen 1 g intravenous given at the beginning and end of surgery.

Placebo

Intervention Type DRUG

Placebo to match acetaminophen given at the beginning and end of surgery.

Placebo First

Patients in this group are presenting for 2 surgeries and will be administered intravenous acetaminophen in one surgery and placebo in the other. Patients in this group will be randomized to receive placebo first.

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen 1 g intravenous given at the beginning and end of surgery.

Placebo

Intervention Type DRUG

Placebo to match acetaminophen given at the beginning and end of surgery.

Interventions

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Acetaminophen

Acetaminophen 1 g intravenous given at the beginning and end of surgery.

Intervention Type DRUG

Placebo

Placebo to match acetaminophen given at the beginning and end of surgery.

Intervention Type DRUG

Other Intervention Names

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Tylenol

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.