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

Brooke Army Medical Center

Status: Unknown

Conditions: Postoperative Pain

Treatments: Drug: Acetaminophen or Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03261310

386486-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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55 participants in 4 patient groups, including a placebo group

Acetaminophen & Craniotomy

Experimental group

Description:

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

Treatment:

Drug: Acetaminophen or Placebo

Placebo & Craniotomy

Placebo Comparator group

Description:

Placebo administered intravenously during craniotomy.

Treatment:

Drug: Acetaminophen or Placebo

Acetaminophen & Laminectomy

Experimental group

Description:

Acetaminophen 1000mg administered intravenously during laminectomy.

Treatment:

Drug: Acetaminophen or Placebo

Placebo & Laminectomy

Placebo Comparator group

Description:

Placebo administered during laminectomy.

Treatment:

Drug: Acetaminophen or Placebo