CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 164 enrolled
Drug / intervention
Methadone +1 moredrug
Likely dose
Methadone 0.3 mg/kgfrom 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/NCT01542645
NCT01542645Phase 4Completed
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The Effect of Choice of Intraoperative Opioid on Postoperative Pain

Endeavor Health·interventional·Posted Mar 2, 2012·Updated Sep 30, 2019

In Brief

A Phase 4 clinical trial evaluating Methadone and Fentanyl for Pain, Postoperative and Chronic Pain. Completed, enrolled 164 participants across 1 site.

Detailed Summary

The primary aim of this randomized, double-blind study is to examine the effect of a single intraoperative dose of methadone on postoperative pain and analgesic requirements in patients undergoing cardiac surgery with cardiopulmonary bypass. These patients will be compared to subjects receiving a standard dose of the "traditional" intraoperative opioid (fentanyl). Secondary outcome measures to be assessed will include standard recovery variables (such as length of postoperative intubation, ICU length of stay, incidence of nausea or vomiting, level of sedation). In addition, patients will be assessed for the development of chronic postoperative pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Postoperative, Chronic Pain
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2012
Enrollment StartSep 1, 2010
Primary CompletionNov 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 14.3 years ago

Interventions

Methadonedrug

Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.

Fentanyldrug

Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.