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

NCT03445390 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 27467
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Count of Participants Requiring Anti-emetic Administration

  Up to 24 hours post-operative

Study Arms (2)

Acetaminophen First

EXPERIMENTAL

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; Drug: Placebo

Placebo First

EXPERIMENTAL

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; Drug: Placebo

Interventions

Acetaminophen DRUG

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

Also known as: Tylenol

Acetaminophen First; Placebo First

Placebo DRUG

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

Acetaminophen First; Placebo First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Mark Burbridge
• Organization: Stanford University

markburb@stanford.edu

(650) 353-8484

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 26, 2018
• Study Start: May 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 1, 2019
• Results First Posted: March 1, 2019

Record last verified: 2019-02

Locations

US (1)