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Completed

NCT Number: NCT03445390

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University Medical Center

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen

Drug

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

Other names: Tylenol

Placebo

Drug

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

Primary outcomes

  1. Post-operative Opioid Consumption

    Time frame: 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.

  2. Post-operative Pain

    Time frame: 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 outcomes

  1. Count of Participants Requiring Anti-emetic Administration

    Time frame: Up to 24 hours post-operative

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Feb 26, 2018
Registry last updated
Mar 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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