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

Sponsor
MercyOne Des Moines Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02102555
Collaborator
(none)
82
Enrollment
1
Location
2
Arms
43
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: IV acetaminophen
  • Drug: placebo
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
May 3, 2017
Actual Study Completion Date :
May 3, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: IV acetaminophen
Single dose of one gram of IV acetaminophen given in pre-operative area
Other Names:
  • Ofirmev
  • paracetamol

    		•
    Placebo Comparator: Placebo

    Patients in the placebo arm will receive normal saline in the pre-operative area.

    Drug: placebo
    placebo (IV normal saline)

    Outcome Measures

    Primary Outcome Measures

    1. postoperative pain [first postoperative day]

      postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting

    Secondary Outcome Measures

    1. postoperative nausea and vomiting (PONV) [first postoperative day]

      patient-rated postoperative nausea and vomiting (PONV) on visual analog scale

    2. time until readiness of discharge [first postoperative day]

      time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)

    3. IV analgesic consumption in recovery room [first postoperative day]

      intravenous analgesic consumption in recovery room: converted to morphine-equivalents

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mercy Medical Center-Des Moines Des Moines Iowa United States 50314

    Sponsors and Collaborators

    • MercyOne Des Moines Medical Center

    Investigators

    • Principal Investigator: Lauren D Allan, DO, Mercy Medical Center-Des Moines General Surgery Residency

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MercyOne Des Moines Medical Center
    ClinicalTrials.gov Identifier:
    NCT02102555
    Other Study ID Numbers:
    • MMC2013-25
    First Posted:
    Apr 3, 2014
    Last Update Posted:
    Jan 14, 2020
    Last Verified:
    Aug 1, 2019
    Additional relevant MeSH terms:
    Nausea
    Vomiting
    Pain, Postoperative
    Postoperative Nausea and Vomiting
    Acetaminophen

    Study Results

    No Results Posted as of Jan 14, 2020