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

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ClinicalTrials.gov Identifier: NCT03445390
Recruitment Status : Completed
First Posted : February 26, 2018
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Burbridge, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Acetaminophen Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy: A Randomized Control Trial
Actual Study Start Date : May 1, 2014
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Tylenol

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Count of Participants Requiring Anti-emetic Administration [ Time Frame: Up to 24 hours post-operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445390


Locations
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United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
  Study Documents (Full-Text)

Documents provided by Mark Burbridge, Stanford University:
Study Protocol  [PDF] May 29, 2013
No Statistical Analysis Plan (SAP) exists for this study.


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Responsible Party: Mark Burbridge, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT03445390     History of Changes
Other Study ID Numbers: 27467
First Posted: February 26, 2018    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics