NCT04290208

A Comparison of IV Versus PO Acetaminophen Postoperatively for Opioid Consumption After Cesarean Section

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Main Line Health · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This randomized controlled study will compare narcotic consumption between two groups: patients that receive a perioperative dose of IV acetaminophen versus patients that receive a perioperative dose of oral liquid acetaminophen for scheduled cesarean section.

Detailed description

"Enhanced recovery" is an alternate management protocol described by a multi-modal, evidence based approach to peri-operative care, with the goal of accelerating recovery and return to normal activity after surgery. Results have shown stable pain control with a decrease in narcotic consumption, a quicker return of bowel function, and decreased length of hospital stay and cost with no change in level of patient satisfaction, morbidity, or readmission rate. An aspect of some alternate management protocols is the administration of acetaminophen. The concentration of acetaminophen in cerebrospinal fluid (CSF) is directly proportional to the analgesic activity of acetaminophen. Acetaminophen relies on a high concentration gradient from the plasma to the CSF in order to passively diffuse into the central nervous system (CNS), its principal site of action. A 2012 study, comparing plasma and CSF pharmacokinetics of intravenous (IV), oral (PO), or rectal (PR) acetaminophen, concluded that IV administration of acetaminophen results in higher plasma and CSF concentration values. Therefore, IV acetaminophen produces better CNS penetration compared to PO or PR methods.

Conditions

• Postoperative Pain
• Cesarean Section
• Acetaminophen

Interventions

Type	Name	Description
DRUG	Acetaminophen	IV Acetaminophen
DRUG	Acetaminophen	Acetaminophen liquid syrup
DRUG	Placebos	Flavored, non-medicated (placebo) liquid syrup
DRUG	Placebos	IV salt solution (non-medicated)

Timeline

• Start date: 2019-08-22
• Primary completion: 2020-06-23
• Completion: 2020-06-23
• First posted: 2020-02-28
• Last updated: 2020-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study