About this 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.
Eligibility criteria
Qualifiers
Pediatric patients aged 1 to 8 years
Scheduled for elective surgery under general anesthesia
Surgery duration < 1 hour
ASA physical status I or II
Disqualifiers
Refusal to participate by parent/guardian
Nasal infections, pathology, or epistaxis
Runny nose or upper respiratory tract infection
Enlarged adenoids
Trial design
Treatments tested in this trial
- Dexmedetomidine + Midazolam 0.4 mg/kg
- Dexmedetomidine + Midazolam 0.2 mg/kg
Treatment groups
Sponsors and collaborators
Cairo University
Lead sponsor
Misr University for Science and Technology
Sponsor institution