Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids

Phase 4

Completed

• Conditions: Psychoses, Substance-Induced
• Interventions: Drug: Ketamine; Drug: Dexmedetomidine

• Registration Number: NCT00205712
• Lead Sponsor: Washington University School of Medicine

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 comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive funct...

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 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 p...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-20
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Results First Submitted: 2009-10-27
• Results First Submitted QC: 2010-03-24
• Results First Posted: 2010-04-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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:

1. Age 7-17 years, inclusive;
2. Are psychiatrically healthy (i.e. have never been under the care of a psychiatrist or taken psychiatrically active medications);
3. Meet American Society of Anesthesiologist (ASA) Class I and II criteria (I=healthy, II=chronic disease under good control);
4. Have had no prior fracture reduction or ketamine administration;
5. Present for care when research assistants are present (Monday-Friday, 09:00-23:00); and
6. 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.

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Exclusion Criteria

1. Solid food intake 2 hours or less before procedure;
2. Compromised cardiorespiratory function; central nervous system, hepatic, or renal abnormality;
3. History of psychosis in patient or first degree relative;
4. Currently taking medications that stimulate or depress mental function, e.g. methylphenidate for attention deficit hyperactivity disorder or drugs of abuse;
5. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine plue saline	Ketamine	Ketamine without dexmedetomidine
Ketamine plus dexmedetomidine	Dexmedetomidine	Ketamine infusion plus dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Brief Psychiatric Ratings Scale (BPRS) Positive Symptom Subscale Score	Before Ketamine, During Ketamine	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)

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Intensity	Before Ketamine, During Ketamine, Post Ketamine and 1 Week Follow up	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	Before Ketamine, During Ketamine, Post Ketamine, 1 week follow up	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.

Trial Locations

Locations (1)

Washington University School of Medicine, Psychiatry Dept.; 🇺🇸 St. Louis, Missouri, United States