CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Ketamine Hydrochloride +3 moredrug
Likely dose
Ketamine Hydrochloride 50 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/NCT02571491
NCT02571491Phase 2Completed

Assessment of the Analgesic Efficacy and Tolerability of the Perioperative Association of the Ketamine With Opiates After Posterior Vertebral Fusion Surgery in Children With Idiopathic Scoliosis

Fundació Sant Joan de Déu·interventional·Posted Oct 8, 2015·Updated Oct 8, 2015

In Brief

A Phase 2 clinical trial evaluating Ketamine Hydrochloride, Placebo, and 2 other interventions for Progressive Infantile Idiopathic Scoliosis. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Comparison of the Efficacy of ketamine measuring the total consumption of morphine in pediatric patients with idiopathic scoliosis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2015
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.7 years ago

Interventions

Ketamine Hydrochloridedrug

50 mg/ml, IV (in the vein) during surgery operation, followed by IV ketamine hydrocloride perfusion 2mcg/Kg/min before and until 72 hours after operation Number of Cycles: until progression or unacceptable toxicity develops.

Placeboother

50 mg/ml, IV (in the vein) during surgery operation, followed by IV placebo perfusion 2mcg/Kg/min before and until 72 hours after operation

Remifentanildrug

at doses of 0.3 mcg / kg / min during and until the end of the surgical operation

Morphine hydrochloridedrug

at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion