CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 68 enrolled
Drug / intervention
IV acetaminophen +1 moredrug
Likely dose
IV acetaminophen 1,000 mgfrom 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/NCT01544062
NCT01544062Phase 4Completed
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Efficacy of Perioperative Intravenous Acetaminophen as an Adjunct Analgesic in Cardiac Surgery Patients

University of Washington·interventional·Posted Mar 5, 2012·Updated Jun 21, 2016

In Brief

A Phase 4 clinical trial evaluating IV acetaminophen and Placebo for Acute Pain and Hyperalgesia. Completed, enrolled 68 participants across 1 site.

Detailed Summary

Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.

Study Details

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

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.3 years ago

Interventions

IV acetaminophendrug

Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Placebodrug

Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.