CompletedPhase 3Phase 4ACTRN12606000246583

Alpha-2 agonists in cardiac kids

Pharmacokinetics and pharmacodynamics of alpha-2 adrenoceptor agonists in children undergoing cardiac surgery

Sponsor

University of Auckland

Enrollment

100 participants

Start Date

Mar 23, 2006

Study Type

Interventional

Conditions

Children undergoing cardiac surgery

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.

Eligibility

Sex: Both males and femalesMin Age: 1 DaysMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates Alpha-2 agonists in cardiac kids. It is open to both men and women, aged 1 to 16. If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

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.

Locations(1)

New Zealand

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ACTRN12606000246583