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Taking peoplePhase 2/3

The PREVENT AGITATION Trial II - Children ≤1 Year

Key facts

Who runs it
Copenhagen University Hospital, Rigshospitalet
Where
Australia and Denmark2 sites in 2 countriesChoose a country to see its sites
Status
Recruiting
Phase
Phase 2/3
People taking part
336 people, planned
Started
25 Oct 2021
Expected to end
31 Jan 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Clonidine
  • Sodium chloride
Record updated
12 August 2026

Who can take part

Age
3 months to 12 months
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
  • Bleeding requiring transfusion prior to scheduled anaesthesia
  • Cardiac, neuro and trauma surgery
  • Critical illness incl. hemodynamic instability (inotropic drugs needed)
  • Malignant disease
  • Cardiac disease incl. arrhythmia
  • Chronic lung disease that may influence study results or study participation in the opinion of the Investigator or may comprise safety and well-being of the patient
  • Neurological disease including symptoms similar to emergence agitation
  • Has or is suspected of having a family or personal history of malignant hyperthermia
  • Has or is suspected of having an allergy to study treatment or its excipients
  • Any condition that can in opinion of the Investigator, deteriorate safety and well-being of the patients or interfere with pharmacokinetic data
  • Positive Covid-19 test or clinical suspicion of Covid-19 (according to current local guidelines)
  • ASA >2
  • Ex-premature (<37 weeks) • Premedication with clonidine
  • Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
  • Mental retardation

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • ClonidineTreatment being tested

    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).

  • PlaceboPlacebo, for comparison

    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.

    Treatment: Sodium chloride

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
12 August 2026