Children who require sedation and analgesia whilst receiving ventilatory support in the paediatric intensive care unit.
Conditions
Interventions
Trade Name: Precedex
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 145108-58-3
Other descriptive name: DEXMEDETOMIDINE HYDROCHLORIDE
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Royal Hospital for Sick Children, Glasgow
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety and efficacy of dexmedetomidine as a sedative agent in ventilated children in the Paediatric Intensive Care Unit;Secondary Objective: Preliminary data on dosage requirements.;Primary end point(s): Acceptable sedation as determined by COMFORT scale Midazolam requirements Dose of dexmedetomidine required | — |
Countries
United Kingdom
Outcome results
None listed