NCT05091242

The PREVENT AGITATION Trial II - Children ≤1 Year

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 3 Months – 12 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Emergence Delirium

Interventions

Type	Name	Description
DRUG	Clonidine	Clonidine injection 3 mcg/kg once
DRUG	Sodium chloride	Sodium chloride 0.9 % injection 0.2 mL/kg once

Timeline

• Start date: 2021-10-25
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2021-10-25
• Last updated: 2024-04-11

Locations

1 site across 1 country: Denmark