Comparing Ketofol and Dexmedetomidine to Prevent Emergence Delirium in Children During Eye Surgery
Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries: A Randomized Controlled Study.
PHASE1; PHASE2 · Cairo University · NCT06545890
This study is testing whether a combination of ketofol can help prevent confusion after eye surgery in young children better than dexmedetomidine.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 2 Years to 6 Years |
| Sex | All |
| Sponsor | Cairo University (other) |
| Locations | 2 sites (Cairo and 1 other locations) |
| Trial ID | NCT06545890 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of ketofol in preventing emergence delirium in pediatric patients undergoing squint surgery, compared to dexmedetomidine. It will assess the incidence of emergence delirium and the adverse effects associated with both medications, including heart rate, mean arterial pressure, recovery time, nausea, and vomiting. The study will be conducted as a prospective randomized controlled double-blinded trial at the Specialized Children Hospital, Cairo University, involving children aged 2 to 6 years with ASA physical status I and II.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 2 to 6 years scheduled for squint surgery with ASA physical status I and II.
Not a fit: Patients who may not benefit include those with known sensitivities to the study medications or neurological diseases affecting postoperative assessment.
Why it matters
Potential benefit: If successful, this study could provide a more effective medication regimen to prevent emergence delirium in children undergoing eye surgeries.
How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific comparison of ketofol and dexmedetomidine in this context is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • All pediatric patients aged 2 to 6 years. * Both sexes. * ASA physical status I and II. * Patients undergoing squint surgery. Exclusion Criteria: * • Refusal of parents. * Patient sensitivity to any of the study medications. * Known neurological disease that can affect the assessment of ED postoperatively.
Where this trial is running
Cairo and 1 other locations
- Abu Elresh Hospitals ( Cairo university ) — Cairo, Egypt (RECRUITING)
- Abu ElResh hospital — Cairo, Egypt (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Muhammad Kh Ibrahim
- Email: dr.mki26413@gmail.com
- Phone: +201032170260
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.
Conditions: Emergence Delirium, ketofol, dexmedetomidine, squint surgeries, children