CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 54 enrolled
Drug / intervention
Ketamine +1 moredrug
Likely dose
Ketamine 0.5mg/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/NCT01325493
NCT01325493Phase 4Completed
CompareCT.gov

Modulation of μ Opioid Receptor Mediated Analgesia, Tolerance and Hyperalgesia in Children and Adolescents

Julia Finkel·interventional·Posted Mar 29, 2011·Updated Jan 14, 2016

In Brief

A Phase 4 clinical trial evaluating Ketamine and Normal Saline for Idiopathic Scoliosis and Spondylolisthesis. Completed, enrolled 54 participants across 1 site.

Detailed Summary

The purpose of this study is to: 1\. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years, undergoing posterior spinal fusion and instrumentation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Scoliosis, Spondylolisthesis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2011
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2012
Study CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.3 years ago

Interventions

Ketaminedrug

ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h

Normal Salinedrug

Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h