Delirium Clinical Trials

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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 all (2) locations...
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
Australia
Perth Children's Hospital, Department of Anaesthesia and Pain Medicine
RECRUITING
Perth
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: 2028-01-31
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