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

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ClinicalTrials.gov Identifier: NCT02102555
Recruitment Status : Terminated (study closed due to difficulty enrolling subjects - no results)
First Posted : April 3, 2014
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
MercyOne Des Moines Medical Center

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
Post Operative Pain Post Operative Nausea and Vomiting 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.


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Study Type : Interventional  (Clinical Trial)
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 : October 2013
Actual Primary Completion Date : May 3, 2017
Actual Study Completion Date : May 3, 2017

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. postoperative nausea and vomiting (PONV) [ Time Frame: first postoperative day ]
    patient-rated postoperative nausea and vomiting (PONV) on visual analog scale

  2. 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)

  3. IV analgesic consumption in recovery room [ Time Frame: first postoperative day ]
    intravenous analgesic consumption in recovery room: converted to morphine-equivalents



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02102555


Locations
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United States, Iowa
Mercy Medical Center-Des Moines
Des Moines, Iowa, United States, 50314
Sponsors and Collaborators
MercyOne Des Moines Medical Center
Investigators
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Principal Investigator: Lauren D Allan, DO Mercy Medical Center-Des Moines General Surgery Residency

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Responsible Party: MercyOne Des Moines Medical Center
ClinicalTrials.gov Identifier: NCT02102555     History of Changes
Other Study ID Numbers: MMC2013-25
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Acetaminophen
Nausea
Vomiting
Pain, Postoperative
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics