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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2

Conditions: Preoperative Anxiety Experienced by the Pediatric Patient; Preoperative Anxiety

Treatments: Drug: Dexmedetomidine + Midazolam 0.2 mg/kg; Drug: Dexmedetomidine + Midazolam 0.4 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT06979791

MD-394-2024

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients aged 1 to 8 years
• Scheduled for elective surgery under general anesthesia
• Surgery duration < 1 hour
• ASA physical status I or II
• Parent or legal guardian able to provide informed consent

Exclusion criteria

• Refusal to participate by parent/guardian
• Nasal infections, pathology, or epistaxis
• Runny nose or upper respiratory tract infection
• Enlarged adenoids
• BMI > 30
• Known allergy to dexmedetomidine or midazolam
• Fever on day of surgery
• Coagulopathy
• Scheduled for cardiothoracic or neurosurgical procedures
• Congenital heart disease
• Neurological or mental disorders
• Pre-existing sedation (MOASS < 5) on the day of surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Dexmedetomidine + Midazolam 0.4 mg/kg

Experimental group

Treatment:

Drug: Dexmedetomidine + Midazolam 0.4 mg/kg

Dexmedetomidine + Midazolam 0.2 mg/kg

Experimental group

Treatment:

Drug: Dexmedetomidine + Midazolam 0.2 mg/kg