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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-8
SponsorCairo University

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Cairo University

Lead sponsor

Misr University for Science and Technology

Sponsor institution