NCT03558555

Determine the Clinical Advantage of IV vs PO Acetaminophen

Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Yan Lai · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Inguinal Hernia

Interventions

Type	Name	Description
DRUG	Acetaminophen IV Soln	1000mg of IV acetaminophen
DRUG	Oral Acetaminophen	oral acetaminophen 975mg pills
DRUG	Placebo Pills	placebo match to acetaminophen
DRUG	Saline	Intravenous saline

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2018-06-15
• Last updated: 2020-02-10
• Results posted: 2020-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study