NCT06979791

Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Year – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Preoperative Anxiety Experienced by the Pediatric Patient
• Preoperative Anxiety

Interventions

Type	Name	Description
DRUG	Dexmedetomidine + Midazolam 0.4 mg/kg	Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.
DRUG	Dexmedetomidine + Midazolam 0.2 mg/kg	Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.

Timeline

• Start date: 2025-06-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-05-20
• Last updated: 2025-05-20

Locations

2 sites across 1 country: Egypt