None listed
Conditions
Brief summary
This is a trial aiming to assess how effective a drug called clonidine is in sedating children in intensive care. Children are normally kept asleep with morphine and midazolam, both sedative drugs with side effects like tolerance and withdrawl. Clonidine acts as a sparing agent, reducing the need for these drugs, and reducing the chance of side effects. This trial aims to show that by using clonidine, we allow a significant reduction in use of morphine and midazolam, and therefore a reduction in side effects. By showing this, we aim to encorporate Clonidine into normal sedation practice, improving our safe practice.
Interventions
Clonidine infusion 0.25-2 mcg/kg/hr in addition to standard sedation -morphine/midazolam infusions
The 'study drug' (clonidine/control) is started at 0.25mcg/kg/hr and increased in hourly increments of 0.25mcg/kg/hr as per study protocol. These increments occur over a 12 hour period, after which time the study drug is maintained, and the patient is actively weaned from morphine and midazolam over the next five 24 hour periods (or until discharge, whichever is sooner). This again follows a prot
Clonidine infusion 0.25-2 mcg/kg/hr in addition to standard sedation -morphine/midazolam infusions The 'study drug' (clonidine/control) is started at 0.25mcg/kg/hr and increased in hourly increments of 0.25mcg/kg/hr as per study protocol. These increments occur over a 12 hour period, after which time the study drug is maintained, and the patient is actively weaned from morphine and midazolam over the next five 24 hour periods (or until discharge, whichever is sooner). This again follows a protocol which allows a 5% reduction in morphine and midazolam every 2 hours. The study drug is continued for this time, and then weaned by 0.25-0.75mcg/kg/hr per hour, after six 24hour periods, or once ready for extubation (whichever is sooner).
Sponsors
Alana Kirkwood
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
patients admitted to PICU during study enrollment period, expected to be ventilated for greater than 24 hours
Exclusion criteria
1. Ventilated less than 24 hours 2. Pre or post-op condition or morbidity precludes the use of the study drug. 3. Hypotension 4. Status Epilepticus 5. Non-pharmacological Coma/ encephalopathy 6. Renal Failure defined as (a)Creatinine Clearance (CrCl)<10ml/min (b)requiring Renal Replacement Therapy (RRT) (c) End Stage Renal Failure (ESRF)
Outcome results
None listed