The PREVENT AGITATION Trial II - Children ≤1 Year

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Treatments: Clonidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)