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

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ClinicalTrials.gov Identifier: NCT03261310
Recruitment Status : Unknown
Verified August 2017 by Dimitar Dentchev, Brooke Army Medical Center.
Recruitment status was:  Recruiting
First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Dimitar Dentchev, Brooke Army Medical Center

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.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Acetaminophen or Placebo Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Use of IV Acetaminophen in the Treatment of Post Operative Pain in Patients Undergoing Craniotomy and Spine Surgery
Study Start Date : May 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acetaminophen & Craniotomy
Drug: Acetaminophen 1000mg administered intravenously during craniotomy
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".

Placebo Comparator: Placebo & Craniotomy
Placebo administered intravenously during craniotomy.
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".

Experimental: Acetaminophen & Laminectomy
Acetaminophen 1000mg administered intravenously during laminectomy.
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".

Placebo Comparator: Placebo & Laminectomy
Placebo administered during laminectomy.
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".




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: 1hour -6 hours ]
    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).


Secondary Outcome Measures :
  1. Opioid administration [ Time Frame: 1 hour-6 hours ]
    Secondary outcome will be a comparison of morphine equivalent dosages of opioid administered during the same periods between the treatment and control groups.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261310


Contacts
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Contact: Dimitar Dentchev, MD 210-916-2118 dimitar.i.dentchev.civ@mail.mil

Locations
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United States, Texas
Brooke Army Medical Center Recruiting
San Antonio, Texas, United States, 78234
Contact: Dimitar Dentchev, MD    210-916-2118    dimitar.i.dentchev.civ@mail.mil   
Principal Investigator: Dimitar Dentchev, MD         
Sponsors and Collaborators
Brooke Army Medical Center
Investigators
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Principal Investigator: Dimitar Dentchev, MD BAMC
Study Chair: Betsy Murray, MD BAMC
Study Chair: Robert Vietor, MD BAMC
Study Chair: Jonathan Deeth, MD BAMC
Study Chair: Daniel Stypula, DO BAMC

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Responsible Party: Dimitar Dentchev, Staff Anesthesiologist, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT03261310     History of Changes
Other Study ID Numbers: 386486-1
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Dimitar Dentchev, Brooke Army Medical Center:
acetaminophen
pain
laminectomy
craniotomy
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics