Dexmedetomidine–midazolam versus ketamine–midazolam for emergence delirium in children
Official title: Prophylactic Effect of Dexmedetomidine-midazolam Versus Ketamine-midazolam on Emergence Delirium After Sevoflurane Anesthesia in Pediatric Cardiac Catheterization: A Randomized Controlled Study.
Run by Kasr El Aini Hospital · NCT07427446 · Data updated 2026-11-12
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 |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Kasr El Aini Hospital Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07427446 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.