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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354378
• Other study ID #: IRB-P00004739
• Status: Completed
• Start date: August 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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)

Related Conditions & MeSH terms

• Dexmedetomidine
• Memory

Intervention

Drug:
• Dexmedetomidine

Other:
• Memory Test

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation Threshold	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.	Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
Secondary	Memory Threshold	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)	Until 100 cards have been presented to the child. Approx. 10 minutes.