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Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

NCT01325493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-01-14

Study results available
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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.

Conditions

  • Idiopathic Scoliosis
  • Spondylolisthesis

Interventions

DRUG

Ketamine

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

DRUG

Normal Saline

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

Sponsors & Collaborators

  • Julia Finkel

    lead OTHER

Principal Investigators

  • Pestieau Sophie, MD · Children's National Research Institute

  • Finkel C Julie, MD · Children's National Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-05-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01325493 on ClinicalTrials.gov