The PREVENT AGITATION Trial II - Children ≤1 Year

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Emergence Delirium

Clinical Trial Details

NCT number	NCT05091242
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact	Bettina Nielsen, PhD
Phone	+4535459546
Email	bettina.nygaard.nielsen@regionh.dk
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	October 25, 2021
Completion date	January 31, 2026

View Details

See also
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