Phase 4 Completed N=86 Randomized Quadruple-blind Treatment

Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

Prostatectomy · Postoperative Pain

Source: ClinicalTrials.gov NCT02369211 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcomePrimary: Post Anesthesia Care Unit Length of Stay — 124; 132 minutes

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Post Anesthesia Care Unit Length of Stay	124; 132	—
PRIMARY Hospital Length of Stay	0.81; 0.82	—
SECONDARY Pain Score	0.62; 0.88	—
SECONDARY Opioid Use	42; 50	—

Eligibility Criteria

Inclusion Criteria

Patients undergoing robotic-assisted laparoscopic prostatectomy
≥18 years old males
American Society of Anesthesiologists class 1-4

Exclusion Criteria

Chronic opiate use
Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
Allergy/hypersensitivity to acetaminophen
Patients with baseline dementia
Chronic diathesis
Chronic kidney disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02369211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.