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Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting (IV)

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.
 
ClinicalTrials.gov Identifier: NCT02102555
Recruitment Status : Terminated (study closed due to difficulty enrolling subjects - no results)
First Posted : April 3, 2014
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
MercyOne Des Moines Medical Center

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE April 3, 2014
Last Update Posted Date January 14, 2020
Study Start Date  ICMJE October 2013
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
postoperative pain [ Time Frame: first postoperative day ]
postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2014)
  • postoperative nausea and vomiting (PONV) [ Time Frame: first postoperative day ]
    patient-rated postoperative nausea and vomiting (PONV) on visual analog scale
  • time until readiness of discharge [ Time Frame: first postoperative day ]
    time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)
  • IV analgesic consumption in recovery room [ Time Frame: first postoperative day ]
    intravenous analgesic consumption in recovery room: converted to morphine-equivalents
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting
Official Title  ICMJE A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting
Brief Summary The purpose of this study is to determine whether a single dose of IV acetaminophen can improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient satisfaction, time to readiness of discharge, and the amount of opiates post operatively will also be measured.
Detailed Description

The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).

IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.

There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.

The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Operative Pain
  • Post Operative Nausea and Vomiting
Intervention  ICMJE
  • Drug: IV acetaminophen
    Single dose of one gram of IV acetaminophen given in pre-operative area
    Other Names:
    • Ofirmev
    • paracetamol
  • Drug: placebo
    placebo (IV normal saline)
Study Arms  ICMJE
  • Active Comparator: IV acetaminophen
    Patients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery.
    Intervention: Drug: IV acetaminophen
  • Placebo Comparator: Placebo
    Patients in the placebo arm will receive normal saline in the pre-operative area.
    Intervention: Drug: placebo
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 Terminated
Actual Enrollment  ICMJE
 (submitted: August 1, 2019)
82
Original Estimated Enrollment  ICMJE
 (submitted: March 31, 2014)
150
Actual Study Completion Date  ICMJE May 3, 2017
Actual Primary Completion Date May 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Each of the following must be met:

  • Greater than or equal to 18 years of age.
  • Female
  • Undergoing outpatient breast surgery (unilateral or bilateral surgery)

Exclusion Criteria:

If ANY of the following apply:

  • History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
  • Chronic alcoholism
  • Severe deficiency of liver and/or kidney
  • Any patient unable to sign informed consent
  • Pregnancy
  • Any patient currently enrolled in another experimental protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (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 NCT02102555
Other Study ID Numbers  ICMJE MMC2013-25
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MercyOne Des Moines Medical Center
Study Sponsor  ICMJE MercyOne Des Moines Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lauren D Allan, DO Mercy Medical Center-Des Moines General Surgery Residency
PRS Account MercyOne Des Moines Medical Center
Verification Date August 2019

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