The PREVENT AGITATION Trial II - Children ≤1 Year

Launched by RIGSHOSPITALET, DENMARK · Oct 22, 2021

Keywords

ClinConnect Summary

The PREVENT AGITATION Trial II is a clinical study aimed at understanding how effective and safe a medication called clonidine is in preventing emergence agitation in young children. Emergence agitation is when a child becomes confused, upset, or restless right after waking up from anesthesia, which can be quite distressing for both the child and their family. This trial focuses on children aged 3 to 12 months who are scheduled to undergo surgery with general anesthesia.

To participate, children must be healthy enough for surgery, and their parents or guardians need to provide written consent. During the study, some children will receive clonidine while others will receive a placebo (a treatment that looks the same but has no active medication) to help researchers compare the effects. Families can expect to be closely monitored for safety and effectiveness throughout the trial. It’s important to know that certain medical conditions may exclude a child from participating, such as serious heart or lung problems, or if the child has a history of allergic reactions to medications.

Gender

ALL

Eligibility 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)