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

The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy: A Randomized Control Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Acetaminophen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Acetaminophen; Acetaminophen 1 g intravenous given at the beginning and end of surgery.; Other Names: Tylenol; Drug: Placebo; Placebo to match acetaminophen given at the beginning and end of surgery.
Experimental: 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.	Drug: Acetaminophen; Acetaminophen 1 g intravenous given at the beginning and end of surgery.; Other Names: Tylenol; Drug: Placebo; Placebo to match acetaminophen given at the beginning and end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Opioid Consumption	From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.	Up to 24 hours post-operative
Post-operative Pain	Patients were asked to rate their pain on a scale of 1 to 10, with 1 being least pain, and 10 being most pain. Pain was assessed continually once per hour during the post-operative period and the average pain score calculated per participant. The average of the participants' average scores is presented for each group.	Up to 24 hours post-operative

Secondary Outcome Measures

Outcome Measure	Time Frame
Count of Participants Requiring Anti-emetic Administration	Up to 24 hours post-operative

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 27467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No