CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 86 enrolled
Drug / intervention
Acetaminophen (Ofirmev) +1 moredrug
Likely dose
Acetaminophen (Ofirmev) 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02369211
NCT02369211Phase 4Completed

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV) in Patients Undergoing Robotic-assisted Laparoscopic Prostatectomy

Brigham and Women's Hospital·interventional·Posted Feb 23, 2015·Updated Sep 11, 2019

In Brief

A Phase 4 clinical trial evaluating Acetaminophen (Ofirmev) and Placebo for Prostatectomy and Pain. Completed, enrolled 86 participants across 1 site.

Detailed Summary

To examine pharmacoeconomics of IV acetaminophen (Ofirmev). Specifically, to examine its potential to improve hospital efficiency and patient outcomes. The investigators compare the addition of IV acetaminophen versus placebo on postoperative anesthesia care unit recovery times, inpatient hospital length of stay (LOS), postoperative pain scores, consumption of opiates as rescue agents and side effects among patients undergoing robotic-assisted laparoscopic prostatectomy (RALP).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatectomy, Pain
CountriesUnited States
CollaboratorsMallinckrodt

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 23, 2015
Enrollment StartSep 1, 2015
Primary CompletionJan 1, 2018
Study CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.4 years ago

Interventions

Acetaminophen (Ofirmev)drug

The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.

Placeboother

The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.