A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-03-31

Brief Summary

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The goal of this study is to determine the effects of dexmedetomidine on memory and recall of children who are receiving dexmedetomidine sedation administered for magnetic resonance imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in children has not been studied.

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Detailed Description

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Conditions

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Memory Dexmedetomidine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Children undergoing sedation with Dexmedetomidine

Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.

Dexmedetomidine

Intervention Type DRUG

Memory Test

Intervention Type OTHER

Children not undergoing sedation

A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.

Memory Test

Intervention Type OTHER

Interventions

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Dexmedetomidine

Intervention Type DRUG

Memory Test

Intervention Type OTHER

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
* The patient must be able to comprehend and perform the task (naming pictures)
* The patient must have a minimum weight of 8 kg

Exclusion Criteria

* Allergy to Dexmedetomidine (for those patients requiring sedation)
* Procedure of short duration (\< 15 min)
* Pregnancy
* Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)

Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No