A Single Dose of Intravenous (IV) Acetaminophen Verses Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | October 2013 |
| Contact: | Lauren DP Allan, DO |
| Email: | lallan@mercydesmoines.org |
| Phone: | 515-661-8191 |
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
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.
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.
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.
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.
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
We found this trial at
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Mercy Medical Center - Des Moines Mercy Medical Center
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