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

Post Operative Pain Clinical Trial

— IV  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02102555
• Other study ID #: MMC2013-25
• Status: Terminated
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: May 3, 2017

Study information

• Verified date: August 2019
• Source: MercyOne Des Moines Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 82
• Est. completion date: May 3, 2017
• Est. primary completion date: May 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Pain, Postoperative
• Post Operative Nausea and Vomiting
• Post Operative Pain
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• IV acetaminophen
Single dose of one gram of IV acetaminophen given in pre-operative area
• placebo
placebo (IV normal saline)

Locations

Country	Name	City	State
United States	Mercy Medical Center-Des Moines	Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
MercyOne Des Moines Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting	first postoperative day
Secondary	postoperative nausea and vomiting (PONV)	patient-rated postoperative nausea and vomiting (PONV) on visual analog scale	first postoperative day
Secondary	time until readiness of discharge	time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)	first postoperative day
Secondary	IV analgesic consumption in recovery room	intravenous analgesic consumption in recovery room: converted to morphine-equivalents	first postoperative day