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.
Who can participate
Age range
3 Months – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of emergence agitation during stay in postanaesthetic care unit (PACU)
Timeframe: From admission to PACU to discharge from PACU, up to app. 4 hours. Emergence agitation is considered present ("Yes"), if Watcha score>2 at ANY time point within the given time frame.
2
Compartmental clearance for pharmacokinetic profiling.
Timeframe: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.
3
Volume of distribution for pharmacokinetic profiling.
Timeframe: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.
4
T1/2 for pharmacokinetic profiling.
Timeframe: Samples will be collected at baseline and at 5, 15, 30, and 60 minutes post dosage and just prior prior to removal of iv-access ie., at latest 120-240 min post dosage.