Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Prevention of NMDA Antagonist-induced Psychosis and Memory Impairment in Children|
- Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score [ Time Frame: Before Ketamine, During Ketamine ] [ Designated as safety issue: No ]Participant received behavioral ratings before medication and during medication for the primary analysis comparison. This is an observer-scale with a value range from 0-6 (0=no symptoms 6=worst symptoms)
- Visual Analog Scale (VAS) Pain Intensity [ Time Frame: Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up ] [ Designated as safety issue: No ]Pain intensity was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
- Visual Analog Scale (VAS) Anxiety Rating [ Time Frame: Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up ] [ Designated as safety issue: No ]Anxiety was measured on a scale of 1-10 (1=lowest pain intensity, 10=highest pain intensity) in participants before medication, during medication, post medication and 1 week follow up.
|Study Start Date:||February 2003|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: Ketamine plue saline
Ketamine without dexmedetomidine
Ketamine without dexmedetomidine
Experimental: Ketamine plus dexmedetomidine
Ketamine infusion plus dexmedetomidine
Ketamine plus dexmedetomidine
Other Name: Precedex
The proposed study will be conducted using existing dedicated clinical and research space in St. Louis Children's Hospital's Emergency Department, Pediatric Clinical Research Center (PCRC), and Orthopedic Clinic. This project has 3 major aims and 1 exploratory aim addressed by a prospective randomized blinded placebo controlled drug trial to test whether a pharmacological strategy can prevent NMDA receptor hypofunction-induced behavioral and cognitive dysfunction in pre- and post-pubertal children. Based on previous preclinical and clinical research on the effects and blockade of the effects of ketamine and similar compounds, the study investigators have carefully selected a dose of the alpha-2 adrenergic agonist dexmedetomidine that will permit this study to be conducted with low risk to enrolled subjects who are undergoing clinically-indicated ketamine sedation for forearm fracture reduction.
General Experimental Design: This project will test the safety and effectiveness of dexmedetomidine for preventing ketamine-induced behavioral and cognitive symptoms in healthy human children undergoing clinically indicated ketamine sedation for forearm fracture reduction.
Aims 1 and 2 will be addressed by randomized, blinded administration of dexmedetomidine or saline placebo to ketamine-sedated subjects to test the efficacy of dexmedetomidine in preventing ketamine-induced behavioral and cognitive changes during recovery from sedation.
Aim 3 will be addressed by comparing between the subjects randomized to receive dexmedetomidine or saline placebo measurements of distress and frequency of adverse cardiopulmonary effects during sedation, fracture-reduction, and recovery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205712
|United States, Missouri|
|Washington University School of Medicine, Psychiatry Dept.|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||John W. Newcomer, M.D.||Washington University School of Medicine and Florida Atlantic University|