CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 84 enrolled
Drug / intervention
Intrathecal morphine +1 moredrug
Likely dose
Not stated in 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/NCT00880607
NCT00880607Phase 4Completed

The Use of Intraoperative Intrathecal Morphine Versus Epidural Extended Release Morphine for Postoperative Pain Control in Pediatric Patients Undergoing Posterior Spinal Fusion

University of Colorado, Denver·interventional·Posted Apr 14, 2009·Updated Apr 22, 2020

In Brief

A Phase 4 clinical trial evaluating Intrathecal morphine and Extended Release Epidural Morphine for Pain Management and 2 related conditions. Completed, enrolled 84 participants across 1 site.

Detailed Summary

This study plans to learn more about preventing pain in children who are having posterior spinal fusion surgery using two different kinds of morphine (a pain medicine). Also, this study plans to learn about individual differences in the how the different kinds of morphine work in children. Subjects are being asked to be in this research study because they are having spinal fusion surgery, will have pain some of the time and will be getting morphine during and after surgery to help control their pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2009
Enrollment StartDec 1, 2008
Primary CompletionApr 1, 2011
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.2 years ago

Interventions

Intrathecal morphinedrug

Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.

Extended Release Epidural Morphinedrug

DepoDur™ is a preparation of extended release lipid encapsulated morphine and is used specifically for epidural injection, outside the spinal fluid, for postoperative pain. This study is a prospective randomized double-blinded trial examining the effectiveness of single dose intrathecal morphine versus single dose extended release epidural morphine for postoperative pain control in pediatric posterior spinal fusion patients.