Evaluating clonidine to reduce emergence agitation in young children
The PREVENT AGITATION Trial II - Children ≤1 Year
This study is testing if a single dose of clonidine can help reduce confusion and agitation in young children aged 3 to 12 months after they wake up from anesthesia.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 336 (estimated) |
| Ages | 3 Months to 12 Months |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05091242 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a single dose of intraoperative clonidine in children aged 3 to 12 months undergoing general anesthesia with sevoflurane. It is a randomized, placebo-controlled study designed to assess the impact of clonidine on emergence agitation, a common postoperative complication characterized by behavioral disturbances. The trial will also evaluate the pharmacokinetics of clonidine in this pediatric population. Participants will be closely monitored for safety and effectiveness throughout the study.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 3 to 12 months scheduled for general anesthesia with sevoflurane.
Not a fit: Patients with ASA classification greater than 2, those undergoing cardiac or neuro surgeries, or those with critical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of emergence agitation in young children after anesthesia, improving their postoperative experience.
How similar studies have performed: Previous studies have shown promising results with clonidine in managing emergence agitation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Copenhagen
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Arash Afshari, PhD — Rigshospitalet, Denmark
- Study coordinator: Bettina Nielsen, PhD
- Email: bettina.nygaard.nielsen@regionh.dk
- Phone: +4535459546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.