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Prevention of agitation and pain after anaesthesia in children less than or equal to 1 year
EU CTIS ID: 2024-520075-28-01
What this study is testing
To evaluate the efficacy of clonidine for prevention of emergence agitation To describe the pharmacokinetic parameters of clonidine when administered as a single dose intraoperatively
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- ASA >2
- 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
See the full eligibility 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
- ASA >2
- 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.