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

Stanford University

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: Acetaminophen

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03445390

27467

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria

Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

27 participants in 2 patient groups

Acetaminophen First

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: Acetaminophen

Placebo First

Experimental group

Description:

Treatment:

Drug: Placebo

Drug: Acetaminophen

Trial documents