The PREVENT AGITATION Trial II - Children ≤1 Year

Who is this study for? Patients with Delirium
What treatments are being studied? Clonidine
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 1
Healthy Volunteers: f
View:

• Paediatric patients (male and female), aged 3- ≤ 12 months

• Scheduled general anaesthesia with sevoflurane and opioid. Induction with propofol is optional

• The legally acceptable representative for the study participant provides written informed consent/assent for the trial

Locations
Other Locations
Denmark
Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Bettina Nielsen, PhD
bettina.nygaard.nielsen@regionh.dk
+4535459546
Backup
Anne Louise B Garioud, MD
anne.louise.de.barros.garioud@regionh.dk
+4535456243
Time Frame
Start Date: 2021-10-25
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 336
Treatments
Experimental: Clonidine
Participants receive Clonidine solution for injection, 3 microg/kg, administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Injection is administered from a dilated solution of Clonidine 15 microg/mL (ie., 0.2 mL/kg).
Placebo_comparator: Placebo
Participants receive Sodium Chloride isotonic (9mg/mL) solution for injection administered intravenously once over 2 minutes approximately 20 minutes before end of procedure. Dosage is administered according to weight: 0.2 mL/kg.
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov

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