NCT01325493

Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Julia Finkel · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-05-01
• Completion: 2012-09-01
• First posted: 2011-03-29
• Last updated: 2016-01-14
• Results posted: 2015-11-02

Locations

1 site across 1 country: United States