Research

Prevention of NMDA Antagonist-Induced Psychosis and Memory Impairment in Children

Reference Number: 201106359

WHAT IS THE PURPOSE OF THE STUDY?

The overall purpose of this research is to determine whether the medicine called dexmedetomidine (Precedex) reduces or stops undesired side-effects of ketamine.

WHO IS NEEDED?

NOTE: Participants must be referred by their emergency room physician.

Physically healthy children between the ages of 7-17 who present to St. Louis Childrens Hospital Emergency Department and require sedation/analgesia to set an acute forearm fracture (and thus are already intended to receive intravenous ketamine). Participants should have no history of psychiatric care or take psychiatric medications.

WHAT IS INVOLVED IF I PARTICIPATE?

Duration: 1-2 weeks
 
Tests/Procedures: -Children seen in the Emergency Room at St. Louis Children's Hospital for a broken bone, and their parents, will be asked questions about their medical history to determine if they are eligible for the study.
-20 children in the study will recieve dexmedetomidine through their IV in addition to the usual ketamine, and 20 children will receive a placebo (saltwater solution) through their IV in addition to the usual ketamine.
-Children will be asked some standard and experimental questions to see how they are feeling, check for side effects, and to check how well they are thinking and remembering. The study questions will take approximately 30-60 minutes to complete, making the stay in the emergency department a little bit longer (about 30 minutes).
-Approximately 11 teaspoons of blood will be drawn during participation.
-At the 1-week follow-up check at the Orthopedic or Surgery Clinic, participants will meet with a member of our staff and will be asked about how they are feeling and if they are having any side effects. We will also repeat the standard and experimental questions to see how well the participant is thinking and remembering. This visit is expected to last between 1 1/2-2 hours.
 
Risks: All risks will be reviewed during the screening.
 
Benefits: The possible benefits to you and society for this research are that participants and other children that get ketamine for painful procedures may be able to get dexmedetomidine to help reduce the problems of feeling strange, seeing things, and being confused as they wake up. If we find dexmedetomidine helps children getting ketamine to have less of these symptoms, it and medicines like it might also be used for people with schizophrenia who have similar symptoms.
 
Compensation: Payments to participants: $100 ($25 for time and inconvenience for the questionnaires and procedures associated with the emergency room visit, and $75 for time and inconvenience of keeping the daily log for 1 week and completing the questionnaires at the 1-week follow-up visit). If you stop participating before the study is done, you will receive $25 for the time and inconvenience for the questionnaires and the procedures associated with the emergency room visit.

WHO IS THE PRINCIPAL INVESTIGATOR (DOCTOR)?

John Newcomer, M.D.
Washington University School of Medicine
314-362-5939
Robert Kennedy, M.D.
St. Louis Children's Hospital
314-454-2825

WHERE WILL THE STUDY TAKE PLACE?

St. Louis Children's Hospital Emergency Room
St. Louis Children's Hospital Department of Orthopedics

CONTACT INFORMATION

Karen Flavin, RN
Washington University School of Medicine
314-362-5242

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