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

Boston Children's Hospital

Status: Completed

Conditions: Dexmedetomidine; Memory

Treatments: Drug: Dexmedetomidine; Other: Memory Test

Study type: Observational

Funder types: Other

Identifiers

NCT02354378

IRB-P00004739

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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)

Trial design

84 participants in 2 patient groups

Children undergoing sedation with Dexmedetomidine

Description:

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.

Treatment:

Other: Memory Test

Drug: Dexmedetomidine

Children not undergoing sedation

Description:

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

Treatment:

Other: Memory Test