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Comparison Between the Effects of Adding Intranasal Dexmedetomidine to Two Different Doses of Midazolam as a Premedication in Pediatrics Undergoing Elective Surgery: A Randomized Controlled Trial
The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are: Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects? How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events? Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects. Participants will: Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam. Undergo sedation scoring at 15 and 30 minutes after drug administration. Be assessed for ease of separation from parents and acceptance of anesthesia mask. Be monitored for vital signs, recovery times, and any perioperative adverse events.
Details
| Lead sponsor | Cairo University |
|---|---|
| Phase | Phase 2 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 60 |
| Start date | 2025-06-01 |
| Completion | 2025-12 |
Conditions
- Preoperative Anxiety Experienced by the Pediatric Patient
- Preoperative Anxiety
Interventions
- Dexmedetomidine + Midazolam 0.4 mg/kg
- Dexmedetomidine + Midazolam 0.2 mg/kg
Primary outcomes
- Mask Acceptance Score (MAS) at time of induction — At the time of induction (approximately 30 minutes after premedication)
Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.
Countries
Egypt