A Pharmacokinetic Study of Dexmedetomine in Infants

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Criteria

Inclusion Criteria:

• Greater than or equal to 1 month, less than or equal to 24 months

• Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period

• Planned tracheal extubation within 24 hours post-operative period

• Renal function-serum creatine = 1.5 times the ULN for age

• Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age

• SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age

• Signed written informed consent

Exclusion Criteria:

• Patients who have received another investigational drug within the past 30 days

• Receiving intermittent or continuous muscle relaxation during study period

• Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.

• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

• Post-Operative hypotension

• Heart block

• Weight < 5 kg

• Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.