Dexmedetomidine as a sedative in paediatric intensive care. - Dexmedetomidine in PIC

Phase 1

• Conditions: Children who require sedation and analgesia whilst receiving ventilatory support in the paediatric intensive care unit.

• Registration Number: EUCTR2006-004836-61-GB
• Lead Sponsor: Royal Hospital for Sick Children, Glasgow

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-09
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Children with a corrected gestational age of >/= 37 weeks to age 18 years
In-patients in Paediatric Intensive Care Unit
Require tracheal intubation and ventilatory support
Anticipated to require sedation for 24 hours or more
Written informed consent from parent or legal guardian
Written informed consent from child if appropriate and possible
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Failure to obtain consent
Patients receiving clonidine for sedation
Allergy to dexmedetomidine
Females of child-bearing age in whom pregnancy has not been disproved
Patients who are breast feeding
Patients receiving neuromuscular blocking drugs for reasons other than performing tracheal intubation
Patients unable for clinical reasons to commence an infusion of morphine for sedation and analgesia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified