None listed
Conditions
Brief summary
The primary purpose of the study is to determine the pharmacokinetics of intravenous clonidine and dexmedetomidine in children as this has not been determined before and will lead to more rational dosing. Once the child is enrolled in the study (following parental consent and child assent, if of age) the child is given a single dose of clonidine or dexmedetomidine once stable in the intensive care unit following surgery. Following administration of the drug, 3 blood samples will be taken at 5 minutes, 3 hours and 8 hours following drug administration. These blood samples will be assayed to determine the plasma concentration of clonidine or dexmedetomidine and allow the determination of the pharmacokinetic profile. Pharmacodynamic data will also be obtained. Blood pressure, heart rate, morphine and benzodiazipine useage will be determined from nursing flow charts and drug charts hourly. The time to extubation will also be noted. This will enable us to determine if clonidine or dexmedetomidine has any effect or BP, HR, analgesic and sedative use and time on mehcanical ventiation.
Interventions
Clonidine is given as a intravenous bolus dose (1-5micrograms/kg) once child is stable in the intensive care unit. Dexmedetomidine is given as an intravenous bolus over 15 minutes (1-4 micrograms/kg) once child is stable in intensive care.
The intervention group are all children (1day to 16 years) who have undergone cardiac surgery at Starship Childrens Hospital.
Sponsors
University of Auckland
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
All children presenting to ICU following cardiac surgery.
Exclusion criteria
Allergy to alpha-2 drugs, haemodynamic instability, parental or child refusal.
Outcome results
None listed