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Trial record 8 of 1889 for:    Acetaminophen

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

Tracking Information
First Submitted Date  ICMJE June 2, 2015
First Posted Date  ICMJE December 31, 2015
Results First Submitted Date  ICMJE November 10, 2017
Results First Posted Date  ICMJE May 7, 2018
Last Update Posted Date July 3, 2018
Actual Study Start Date  ICMJE August 17, 2015
Actual Primary Completion Date September 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Postoperative pain score [ Time Frame: 1-h postoperatively ]
1-h postoperatively in the Post-Anesthesia Care Unit (PACU)
Change History Complete list of historical versions of study NCT02643394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2015)
Postoperative opioid usage [ Time Frame: Postoperative opioid usage in PACU, an expected average of 6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Oral vs. Intravenous Acetaminophen
Official Title  ICMJE The Comparative Efficacy of Oral vs. Intravenous Acetaminophen in Sinus Surgery Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Oral Acetaminophen
    1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
    Other Name: Tylenol
  • 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
Study Arms  ICMJE
  • Active Comparator: Oral Acetaminophen
    Oral Acetaminophen 1-hour before surgery
    Intervention: Drug: Oral Acetaminophen
  • Active Comparator: Intravenous Acetaminophen
    Intravenous Acetaminophen within 1-hour prior to anesthetic emergence
    Intervention: Drug: Intravenous acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2015)
100
Actual Study Completion Date  ICMJE January 15, 2018
Actual Primary Completion Date September 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02643394
Other Study ID Numbers  ICMJE 052015-068
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David McDonagh, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP