Determine the Clinical Advantage of IV vs PO Acetaminophen
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 1/31/2019 |
| Start Date: | December 8, 2017 |
| End Date: | December 30, 2018 |
Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
There is limited research on the clinical outcome differences between intravenous (IV)
acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen
sometimes being almost 100 times the cost of PO acetaminophen, it is not only important
fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The
proposed research study is to determine the clinical advantages of IV vs PO acetaminophen
during the post-operative recovery time for ambulatory surgery patients by analyzing
differences in time to first opioid delivery, pain scores, and patient satisfaction.
acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen
sometimes being almost 100 times the cost of PO acetaminophen, it is not only important
fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The
proposed research study is to determine the clinical advantages of IV vs PO acetaminophen
during the post-operative recovery time for ambulatory surgery patients by analyzing
differences in time to first opioid delivery, pain scores, and patient satisfaction.
In previous literature it has been shown that compared to placebo, IV acetaminophen can
improve postoperative pain scores and reduce opioid requirements. In addition, IV
acetaminophen has several pharmacokinetic properties that may be beneficial when compared to
acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum
plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative
effectiveness trials of IV vs PO administration have not conclusively demonstrated improved
clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be
conducted to determine possible clinical advantages.
improve postoperative pain scores and reduce opioid requirements. In addition, IV
acetaminophen has several pharmacokinetic properties that may be beneficial when compared to
acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum
plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative
effectiveness trials of IV vs PO administration have not conclusively demonstrated improved
clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be
conducted to determine possible clinical advantages.
Inclusion Criteria:
- ASA scores I-III
- Ambulatory surgery patients
- Ages 18-75
- Surgeries requiring general anesthesia for hernia surgery
Exclusion Criteria:
- Patients with contraindications to acetaminophen (history of end organ liver
dysfunction)
- Known allergy to acetaminophen
- Emergency surgery
- Patients who were not fasted
- Patients who cannot tolerate PO
- Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
- Pregnancy
- Weight less than 50kg
- Chronic daily narcotic use
- Patients who's anesthetic plan requires regional anesthesia
- Patient refusal to participate or do not have capacity to provide consent.
We found this trial at
1
site
New York, New York 10019
Principal Investigator: Yan Lai, MD, MPH
Phone: 212-523-4000
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