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RECRUITING
NCT05091242
PHASE2/PHASE3

The PREVENT AGITATION Trial II - Children ≤1 Year

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

Interventions

DRUG

Clonidine

Clonidine injection 3 mcg/kg once

DRUG

Sodium chloride

Sodium chloride 0.9 % injection 0.2 mL/kg once

Locations (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark