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Comparison of the Efficacy of Ketamine in Pediatric Patients With Idiopathic Scoliosis After Surgery

NCT02571491 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2015-10-08

No results posted yet for this study

Summary

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

Conditions

  • Progressive Infantile Idiopathic Scoliosis

Interventions

DRUG

Ketamine Hydrochloride

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.

OTHER

Placebo

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

DRUG

Remifentanil

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

DRUG

Morphine hydrochloride

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

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Marina Perelló Riera, MD · Hospital Sant Joan de Déu Servicio de Anestesiología, Reanimación y Tratamiento del Dolor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571491 on ClinicalTrials.gov