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The PREVENT AGITATION Trial II - Children ≤1 Year

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jan 31, 2026 to Jan 31, 2028
    • Study sites: 1 to 2
    v6
  2. Primary and study completion dates: Jan 31, 2024 to Jan 31, 2026v5
  3. Study Status, Referencesv4
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Oct 14, 2021 to Oct 25, 2021v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05091242
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)		 Emergence Delirium
Related terms Emergence Delirium, Postoperative Nausea and Vomiting, Postoperative Pain
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov