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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445390
• Other study ID #: 27467
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2014
• Est. completion date: November 1, 2017

Study information

• Verified date: February 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: November 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Acetaminophen
Acetaminophen 1 g intravenous given at the beginning and end of surgery.
• Placebo
Placebo to match acetaminophen given at the beginning and end of surgery.

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Count of Participants Requiring Anti-emetic Administration		Up to 24 hours post-operative