Dexmedetomidine for Sedation in Medical Procedures – Phase IV

Dexmedetomidine in Pediatric Subjects Undergoing Procedure-Type Sedation

Protocol Description

This study is being done to determine the safety and effectiveness of dexmedetomidine on children who are having a medical procedure or surgery to treat an illness, or a testing procedure to diagnose an illness, either of which requires sedation. The medicine, which will be provided as a calming agent before a procedure, is approved for adults, but is not yet approved for children.

Study Level: Phase IV

Eligibility Criteria

Subject to certain exclusion criteria, the study is open to patients in the Cardiac Intensive Care Unit who are having a medical procedure that requires a sedative and is expected to take more than 30 minutes.
Boys and Girls: Ages 1 through 16

Requirements

The study drug will be provided via continuous infusion at a dosage based on patient size. Vital sign monitoring will begin prior to testing, treatment or surgery, and will continue during and after the procedure until the patient is released. Follow-up will be done after 24 hours and again after 30 days.
Visits: Up to 3
Duration: Up to 45 days

Status: Open to Enrollment

Source(s) of Support

Hospira, Inc.

Contact Information

For information, please contact:
Kelli Shepler, CRC
412-692-6061