The PREVENT AGITATION Trial II - Children ≤1 Year
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- STATUS
- Recruiting
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- End date
- Jan 31, 2024
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- participants needed
- 336
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- 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.
Details
| Condition | Emergence Delirium |
|---|---|
| Treatment | clonidine, Sodium chloride |
| Clinical Study Identifier | NCT05091242 |
| Sponsor | Rigshospitalet, Denmark |
| Last Modified on | 9 April 2023 |
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