Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

Postoperative Pain Clinical Trial

Official title:

Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261310
• Other study ID #: 386486-1
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2014
• Last updated: August 23, 2017
• Start date: May 2013
• Est. completion date: July 2018

Study information

• Verified date: August 2017
• Source: Brooke Army Medical Center
• Contact: Dimitar Dentchev, MD
• Phone: 210-916-2118
• Email: dimitar.i.dentchev.civ[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Description:

The purpose of this study is to investigate the effectiveness of intravenous acetaminophen (Tylenol) for post operative pain control in patients undergoing craniotomies (brain surgery) and spine surgery. Studies have shown that intravenous acetaminophen is useful for post operative pain control in some operations but there have not been studies to evaluate the use of acetaminophen in craniotomies or spine surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 years old

• undergoing non-emergent craniotomy or single level lumbar laminectomy

• must be able to rate pain on a 0-10 scale post-operatively

Exclusion Criteria:

• history of liver disease

• allergy to acetaminophen

• age less than 18 years

• renal failure with creatinine clearance less than 30

• pregnancy

• altered mentation with inability to report pain score

• patients who have received acetaminophen within 6 hours of surgery

• patients in which a neuraxial technique has been performed for surgery

• prisoners

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Acetaminophen or Placebo
Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for "No acetaminophen for 6 hours post operatively".

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores	Primary outcomes will be measured pain scores at post-operative timepoints (1, 2, 4 and 6 hours), and the calculated percent change from baseline (1 hr post-op) for each of the follow-up pain scores (2, 4, 6 hours).	1hour -6 hours
Secondary	Opioid administration	Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.	1 hour-6 hours