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Not Yet RecruitingPhase 4ACTRN12610000079044

Synergistic effect of Clonidine on sedation requirements in Paediatric Intensive Care (PICU)

In children ventilated in Paediatric Intensive Care (PICU), does clonidine added to standard sedation, when compared to control, provide a statistically significant reduction in overall consumption of standard sedation.

Sponsor

Alana Kirkwood

Enrollment

120 participants

Start Date

Feb 1, 2010

Study Type

Interventional

Conditions

sedation in critical illness

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.

Eligibility

Sex: Both males and femalesMin Age: 1 MonthsMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether adding the medication clonidine can reduce the amount of sedation drugs needed for children on breathing machines in pediatric intensive care. It is for children aged 1 month to 18 years who are expected to need ventilation for more than 24 hours.

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 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 increment

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).

Locations(1)

Australia

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ACTRN12610000079044