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The PREVENT AGITATION Trial II - Children ≤1 Year
Sponsor: Rigshospitalet, Denmark
Summary
Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.
Key Details
Gender
All
Age Range
3 Months - 12 Months
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2021-10-25
Completion Date
2026-01-31
Last Updated
2024-04-11
Healthy Volunteers
No
Conditions
Interventions
Clonidine
Clonidine injection 3 mcg/kg once
Sodium chloride
Sodium chloride 0.9 % injection 0.2 mL/kg once
Locations (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark