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

NCT ID: NCT03261310

Last Updated: 2017-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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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

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Acetaminophen & Craniotomy

Drug: Acetaminophen 1000mg administered intravenously during craniotomy

Group Type EXPERIMENTAL

Acetaminophen or Placebo

Intervention Type DRUG

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".

Placebo & Craniotomy

Placebo administered intravenously during craniotomy.

Group Type PLACEBO_COMPARATOR

Acetaminophen or Placebo

Intervention Type DRUG

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".

Acetaminophen & Laminectomy

Acetaminophen 1000mg administered intravenously during laminectomy.

Group Type EXPERIMENTAL

Acetaminophen or Placebo

Intervention Type DRUG

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".

Placebo & Laminectomy

Placebo administered during laminectomy.

Group Type PLACEBO_COMPARATOR

Acetaminophen or Placebo

Intervention Type DRUG

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".

Interventions

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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".

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Dimitar Dentchev

Staff Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dimitar Dentchev, MD

Role: PRINCIPAL_INVESTIGATOR

BAMC

Betsy Murray, MD

Role: STUDY_CHAIR

BAMC

Robert Vietor, MD

Role: STUDY_CHAIR

BAMC

Jonathan Deeth, MD

Role: STUDY_CHAIR

BAMC

Daniel Stypula, DO

Role: STUDY_CHAIR

BAMC

Locations

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Brooke Army Medical Center

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dimitar Dentchev, MD

Role: CONTACT

210-916-2118

Facility Contacts

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Dimitar Dentchev, MD

Role: primary

210-916-2118

Other Identifiers

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386486-1

Identifier Type: -

Identifier Source: org_study_id

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