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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03261310
Other study ID # 386486-1
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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