Comparing two medications for better recovery in children after tonsil surgery
Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.
This study is testing which of two medication combinations helps children recover better after tonsil surgery by looking at things like confusion, nausea, and overall satisfaction.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 3 Years to 10 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 2 sites (Maadi, Cairo and 1 other locations) |
| Trial ID | NCT06010927 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of two different premedication approaches on the recovery profile of pediatric patients undergoing adenotonsillectomy. It compares the combination of ketamine and midazolam administered intramuscularly with a pre-extubation mixture of ketamine and propofol, known as Ketofol. The goal is to determine which method leads to less emergence delirium, improved vital signs, reduced postoperative nausea and vomiting, and overall better satisfaction for patients and their parents. The study focuses on children classified as ASA physical status I or II scheduled for general anesthesia.
Who should consider this trial
Good fit: Ideal candidates for this study are children classified as ASA physical status I or II who are scheduled for adenotonsillectomy under general anesthesia.
Not a fit: Patients with congenital cardiovascular anomalies, behavioral changes, delayed physical development, or those receiving sedatives or anticonvulsants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences for children undergoing tonsil surgery, minimizing complications like emergence delirium and postoperative nausea.
How similar studies have performed: Previous studies have shown varying results regarding the effectiveness of ketamine and midazolam versus Ketofol, indicating that this area of research is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status I or II * Children scheduled for AT under general anesthesia (GA). Exclusion Criteria: * Congenital cardiovascular anomalies * Behavioral changes * Delayed physical development * Children receiving sedatives or anticonvulsants therapy
Where this trial is running
Maadi, Cairo and 1 other locations
- Abeer Ahmed — Maadi, Cairo, Egypt (Recruiting)
- Anesthesia department - Faculty of medicine- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Abeer Ahmed
- Email: abeer_ahmed@kasralainy.edu.eg
- Phone: 01005244590
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.