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Trial record 1 of 1 for:    NCT01598701
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Intravenous Acetaminophen in Craniotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01598701
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : June 19, 2018
Last Update Posted : June 19, 2018
Information provided by (Responsible Party):
Carlos Artime, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to assess the use of intravenous Acetaminophen (OFIRMEV) as an effective adjunct therapeutic agent in patients undergoing craniotomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Acetaminophen Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Opioid-Sparing and Analgesic Effects of IV Acetaminophen in Craniotomy: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Actual Study Start Date : May 2, 2012
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 30, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intravenous Acetaminophen
Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.
Drug: Acetaminophen
Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.
Other Name: OFIRMEV

Placebo Comparator: Placebo
Patients will be given 100 mL normal saline placebos at scheduled time intervals in place of IV acetaminophen.
Drug: Placebo
100 mL 0.9% Sodium Chloride
Other Name: 0.9% Sodium Chloride

Primary Outcome Measures :
  1. Post-Operative Opioid Requirement [ Time Frame: 24 hours post-operatively ]
    Opioid Consumption will be monitored in the first 24 post-operative hours. All non-opioid analgesics are disallowed. Total opioid consumption was calculated based on morphine equivalents (MEs), where 1 mg of IV morphine was equivalent to 1 ME, and 1 mg IV hydromorphone was calculated as 7 MEs.

Secondary Outcome Measures :
  1. Post-Operative Pain [ Time Frame: 24 Hours Post-Operatively ]
    Patients will be assessed for pain using a Visual Analogue Scale (VAS) Scale at set time points after surgery (0,1,2,4,8,12,16,20,24 hours post-operatively). The Visual Analogue Scale (VAS) scale was measured on a scale of 0 - 10 (0 = no pain, 1-3 = mild, 4-6 = moderate, 7-10 = severe). Higher values on the VAS represent a worse outcome. The two rows below report: 1. the average VAS score for the least amount of pain reported per group and 2. the average VAS score of the worst amount of pain reported per group.

  2. Post-Operative Side Effects [ Time Frame: 24 Hours Post-Operatively ]
    Patients will be monitored for 24 hours post-operatively to detect the incidence of any drug or opioid-related side effects. These side effects were not considered to be adverse events.

  3. Time to Extubation at Emergence From Anesthesia [ Time Frame: Time from of discontinuation of anesthetic to time of extubation, an average of 7 minutes ]
  4. Time for Patient to Meet Post-anesthesia Care Unit (PACU) Discharge Criteria [ Time Frame: From time of entry to PACU to time to meet PACU discharge criteria, an average of 12 minutes ]

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adults
  • Undergoing Craniotomy for Supratentorial Tumor Resection
  • Weight between 50 and 120 kilograms
  • ASA Physical Status I-III
  • Be able to communicate verbally
  • Be able to use Visual Analog Score

Exclusion Criteria:

  • Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
  • Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days prior to the day of surgery.
  • Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
  • Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine > 2mg/dl).
  • Known or suspected history of alcohol or illicit drug abuse.
  • Pregnant or breast-feeding.
  • Surgical plan for infratentorial (suboccipital) craniotomy.
  • Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
  • Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
  • Uncontrolled Hypertension

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 identifier (NCT number): NCT01598701

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United States, Texas
Memorial Hermann Hospital - Texas Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
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Principal Investigator: Carlos A. Artime, MD University of Texas Health Sciences Center at Houston
Principal Investigator: Sam D. Gumbert, MD University of Texas Health Sciences Center at Houston

Publications of Results:
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Responsible Party: Carlos Artime, Assistant Professor - Anesthesiology, The University of Texas Health Science Center, Houston Identifier: NCT01598701    
Other Study ID Numbers: HSC-MS-12-0055
First Posted: May 15, 2012    Key Record Dates
Results First Posted: June 19, 2018
Last Update Posted: June 19, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Carlos Artime, The University of Texas Health Science Center, Houston:
Intravenous Acetaminophen
Opioid Requirement
Post-Operative Pain
Post-Craniotomy Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs