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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Acetaminophen; Drug: Placebo

• Registration Number: NCT03445390
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-11-01
• Study First Submitted: 2018-02-20
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Results First Submitted: 2018-12-06
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-06
• Last Update Submitted: 2019-02-06
• Results First Posted: 2019-03-01
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acetaminophen First	Placebo	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.
Placebo First	Placebo	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.
Acetaminophen First	Acetaminophen	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.
Placebo First	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
Post-operative Opioid Consumption	Up to 24 hours post-operative	From nursing records how much opioid was administered to each patient post-operatively. Opioid use was measured in micrograms (ug) of fentanyl.
Post-operative Pain	Up to 24 hours post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Count of Participants Requiring Anti-emetic Administration	Up to 24 hours post-operative

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States