Trial intelligence / Profile preview

Rectal Acetaminophen in Oocyte Retrieval

NCT03732469Phase 4

Key facts

Status: Terminated
Start: Nov 2019
Primary completion: Dec 2020
Countries: 1
Sponsor: University of South Florida
Modality: Small Molecules

Drugs: acetaminophen
Conditions: postoperative pain

Overview

Phase 4, randomised, single-blind trial of acetaminophen in postoperative pain (2 arms), sponsored by University of South Florida. Primary endpoint: Proportion of prescribed Tylenol with Codeine utilized at 72 hours. Started Nov 2019; status: terminated.

Design

2 arms

Study design: RandomizedSingle-blind

Fentanyl/propofol + acetaminophen
Standard anesthesia (Fentanyl/Propofol) + Rectal Acetaminophen (1300 mg)
Fentanyl/propofol only
Standard anesthesia (Fentanyl/Propofol) only

Who it enrols

Female patients undergoing oocyte retrieval, excluding those with chronic pain, BMI > 40, liver disease, or history of substance abuse.

Endpoints

Primary

Proportion of prescribed Tylenol with Codeine utilized72 hours

Secondary

Pain score in post-anesthesia care unit using the Visual Analog Scale1 hour
24-hour pain score using the Visual Analog Scale24 hours
48-hour pain score using the Visual Analog Scale48 hours
72-hour pain score using the Visual Analog Scale72 hours

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