Status:
COMPLETED
Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Psychoses, Substance-Induced
Eligibility:
All Genders
7-17 years
Phase:
PHASE4
Brief Summary
Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in compa...
Detailed Description
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 Orthop...
Eligibility Criteria
Inclusion
- Patients presenting to St. Louis Children's Hospital's Emergency Department who require reduction of an acute forearm fracture will be recruited for enrollment if they satisfy the following:
- Age 7-17 years, inclusive;
- Are psychiatrically healthy (i.e. have never been under the care of a psychiatrist or taken psychiatrically active medications);
- Meet American Society of Anesthesiologist (ASA) Class I and II criteria (I=healthy, II=chronic disease under good control);
- Have had no prior fracture reduction or ketamine administration;
- Present for care when research assistants are present (Monday-Friday, 09:00-23:00); and
- Have a home telephone or ready means of establishing telephone contact.
- All subjects and their parent/guardian will give Washington University Human Studies Committee approved written informed assent and consent prior to participation.
Exclusion
- Solid food intake 2 hours or less before procedure;
- Compromised cardiorespiratory function; central nervous system, hepatic, or renal abnormality;
- History of psychosis in patient or first degree relative;
- Currently taking medications that stimulate or depress mental function, e.g. methylphenidate for attention deficit hyperactivity disorder or drugs of abuse;
- History of allergy or adverse reaction to alpha-2 adrenoreceptor agonist drugs, e.g. clonidine.
- These exclusion criteria relate to contraindications for use of the agents employed in the study. Criteria 1, 2, 3 and 4 are current routine practice for ketamine sedations.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00205712
Start Date
February 1 2003
End Date
October 1 2007
Last Update
January 14 2016
Active Locations (1)
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1
Washington University School of Medicine, Psychiatry Dept.
St Louis, Missouri, United States, 63110