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Efficacy of Oral vs. Intravenous Acetaminophen

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ClinicalTrials.gov Identifier: NCT02643394
Recruitment Status : Completed
First Posted : December 31, 2015
Results First Posted : May 7, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Oral Acetaminophen Drug: Intravenous acetaminophen Phase 4

Detailed Description:

The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen is understudied and largely unknown. Intravenous acetaminophen has been available since 2010 (http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022450lbl.pdf) and has proven superiority over placebo in human clinical trials. It is clearly advantageous in patients who cannot take oral medications. Similarly, oral acetaminophen has proven efficacy in the management of postoperative pain.

However, in patients who can receive either formulation the incremental cost of the IV formulation, both to the Health System and patient, is substantial. This incremental cost would be justifiable if there were clear efficacy or safety data to support the preferential use of IV over PO acetaminophen.

However, there is no evidence of superior safety and there are only two studies to our knowledge investigating the question of comparative efficacy. Fenlon et al. randomized 130 patients undergoing 3rd molar (i.e., wisdom tooth) removal to IV vs. PO acetaminophen and found that PO acetaminophen was non-inferior to IV acetaminophen. The primary endpoint was postoperative pain score 1h after surgery. No safety concerns were identified in either group. Pettersson et al. randomized cardiac surgery patients to IV or PO acetaminophen, starting immediately postoperatively through the following morning, and found a significant opioid sparing effect of IV acetaminophen but no difference in pain scores or nausea.

IV acetaminophen avoids first-pass hepatic metabolism and therefore generates higher serum and cerebrospinal fluid (CSF)/brain levels than does PO acetaminophen (http://ofirmev.com/Pharmacokinetics/). Based on the pharmacokinetic data, one can hypothesize that IV acetaminophen would be superior to PO acetaminophen at time points where serum and/or cerebrospinal fluid drug levels are higher.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Comparative Efficacy of Oral vs. Intravenous Acetaminophen in Sinus Surgery Patients
Actual Study Start Date : August 17, 2015
Actual Primary Completion Date : September 2, 2016
Actual Study Completion Date : January 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Oral Acetaminophen
Oral Acetaminophen 1-hour before surgery
Drug: Oral Acetaminophen
1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
Other Name: Tylenol

Active Comparator: Intravenous Acetaminophen
Intravenous Acetaminophen within 1-hour prior to anesthetic emergence
Drug: Intravenous acetaminophen
400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
Other Name: Tylenol




Primary Outcome Measures :
  1. Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain) [ Time Frame: 1-h postoperatively ]
    Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)


Secondary Outcome Measures :
  1. Morphine Equivalents of Postoperative Opioid Usage [ Time Frame: an expected average of 6 hours ]
    Total amount of postoperative opioid usage at Postoperative Anesthesia Care Unit (PACU), an expected average of 6 hours



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients aged 18 years or older
  • Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

  • Inability of the patient to follow directions or comprehend either English or Spanish language.

    • Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
    • Patients with chronic pain manifest by a baseline pain score > 4/10
    • Chronic opioid use (>2 weeks continuously), or illicit drug abuse
    • Body weight < 50 kg.
    • Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
    • Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
    • Allergy to acetaminophen

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): NCT02643394


Locations
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United States, Texas
Zale Lipshy University Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: David McDonagh, MD UT Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02643394     History of Changes
Other Study ID Numbers: 052015-068
First Posted: December 31, 2015    Key Record Dates
Results First Posted: May 7, 2018
Last Update Posted: July 3, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Texas Southwestern Medical Center:
Acetaminophen
Postoperative pain
Sinus Surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics