The PREVENT AGITATION Trial II - Children ≤1 Year
Rigshospitalet, Denmark
336 participants
Oct 25, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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
Exclusion Criteria16
- ASA >2
- Cardiac, neuro and trauma surgery
- Ex-premature (<37 weeks) • Premedication with clonidine
- Intubated prior to scheduled anaesthesia or is expected to require intubation after the procedure
- Critical illness incl. hemodynamic instability (inotropic drugs needed)
- Bleeding requiring transfusion prior to scheduled anaesthesia
- Planned for a postoperative nurse-controlled analgesia pump including a continuous infusion of opioid
- 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
- Mental retardation
- 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)
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Clonidine injection 3 mcg/kg once
Sodium chloride 0.9 % injection 0.2 mL/kg once
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05091242