Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children
Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
This test compares dexmedetomidine plus midazolam against ketamine plus midazolam to see which better prevents emergence delirium in children having heart catheterization under general anesthesia.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07427446 on ClinicalTrials.gov |
What this trial studies
Fifty children scheduled for elective cardiac catheterization without local skin anesthesia are randomly assigned to one of two IV sedation regimens. The dexmedetomidine–midazolam group receives dexmedetomidine 1 µg/kg over 10 minutes and midazolam 0.1 mg/kg at induction, followed by dexmedetomidine 0.5 µg/kg/h and midazolam 0.1 mg/kg/h infusions for maintenance. The ketamine–midazolam group receives ketamine 1 mg/kg and midazolam 0.1 mg/kg at induction, followed by ketamine 1 mg/kg/h and midazolam 0.1 mg/kg/h infusions. Emergence delirium and recovery characteristics are compared between groups at a single center (Kasralainy Hospital, Cairo) in this Phase 4 interventional trial.
Who should consider this trial
Good fit: Children scheduled for elective cardiac catheterization under general anesthesia who do not have neurological or psychiatric disorders, are not on psychoactive medications, and have no significant systemic comorbidities are ideal candidates.
Not a fit: Children with neurological or psychiatric disorders, current psychoactive medication use, allergies to the study drugs, or significant systemic comorbidities would likely be excluded and may not benefit from the study interventions.
Why it matters
Potential benefit: If successful, the preferred regimen could reduce how often and how severely children experience emergence delirium after cardiac catheterization, improving recovery comfort and safety.
How similar studies have performed: Previous studies have shown dexmedetomidine can reduce emergence delirium in pediatric anesthesia while ketamine results are mixed, so this head-to-head comparison builds on some supporting evidence but direct comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for elective cardiac catheterization under general anesthesia. Exclusion Criteria: * neurological disorder, psychiatric disease, or current psychoactive medication. * allergy. * significant systemic comorbidities.
Where this trial is running
Cairo
- Kasralainy Hospital — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmed Elhaddad, Ass.prof. — Faculty of medicins,Cairo university
- Study coordinator: Ahmed Elhaddad, Ass.prof.
- Email: drblacksmith@gmail.com
- Phone: 01224042847
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.