Recruiting

Acetaminophen

Sponsor:

Brooke Army Medical Center

Code:

NCT03261310

Conditions

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Acetaminophen or Placebo

Study Details

Brief 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.

Conditions

Postoperative Pain

Study ID

NCT03261310

Start date

May, 2013

Status verified date

Aug, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

Jul, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Acetaminophen & Craniotomy

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

placebo comparator: Placebo & Craniotomy

Placebo administered intravenously during craniotomy.

experimental: Acetaminophen & Laminectomy

Acetaminophen 1000mg administered intravenously during laminectomy.

placebo comparator: Placebo & Laminectomy

Placebo administered during laminectomy.

Interventions

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".

Primary outcome measure

  • Pain Scores [ Time Frame: 1hour -6 hours ]

Central Contacts and Locations

Central contacts

Dimitar Dentchev, MD

210-916-2118dimitar.i.dentchev.civ@mail.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Dimitar Dentchev, MD

210-916-2118dimitar.i.dentchev.civ@mail.mil

Principal Investigator:

Dimitar Dentchev, MD

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Aug 25, 2017

Last verified

Aug, 2017

Keywords

  • acetaminophen
  • pain
  • laminectomy
  • craniotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2017-08-25.