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Completed

NCT Number: NCT02354378

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

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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Key information

Conditions

Memory Dexmedetomidine

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Dexmedetomidine

Drug

Other names: Precedex

memory test

Other

Primary outcomes

  1. Sedation Threshold

    Time frame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards

    During the 10-minute bolus infusion of Dexmedetomidine, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.

Secondary outcomes

  1. Memory Threshold

    Time frame: Until 100 cards have been presented to the child. Approx. 10 minutes.

    At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives)

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2015
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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