The PREVENT AGITATION Trial II - Children ≤1 Year

Rigshospitalet

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Emergence Delirium

Treatments: Drug: Sodium chloride; Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05091242

20200708

2020-005409-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 336 estimated patients

Sex: All

Ages: 3 to 12 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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336 participants in 2 patient groups, including a placebo group

Clonidine

Experimental group

Description:

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).

Treatment:

Drug: Clonidine

Placebo

Placebo Comparator group

Description:

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:

Drug: Sodium chloride