Intranasal Dexmedetomidine Versus Intranasal Midazolam as a Premedication in Pediatrics Undergoing Upper GI Endoscopy

Ain Shams University

Status and phase: Not yet enrolling; Phase 4

Conditions: Anesthesia

Treatments: Drug: Midazolam; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06181682

ASU MS

Details and patient eligibility

About

compare the effectiveness of intranasal dexmedetomidine and midazolam as a premedication in sedation of preschool children in GI endoscopy

Enrollment: 70 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children of preschool age (2-6 years old).
• American scocity of anaesthesiology (ASA) I - II children.
• Expected duration of the procedure is less than 50 minutes.

Exclusion criteria

• Cardiac arrhythmia, congenital heart disease, or hemodynamic or respiratory instability; children at risk for airway obstruction.
• Behavioral, mental or developmental abnormality (example: mental retardation, Attention Deficit Hyperactivity Disorder "ADHD", Autism, Down syndrome).
• Regular intake of either brain stimulant or depressive drugs (example: Methylphenidate, amphetamine-dextroamphetamine and diazepam respectively).
• Parent's refusal.
• Emergency case.
• Allergy to any of the used drugs

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

dexmedetomidine group

Active Comparator group

Description:

patients will receive intranasal dexmedetomidine (1 microgram/kg) -Intranasal dexmedetomidine will be prepared from the 100 mcg/ml parenteral preparation in a 1-ml syringe, and 0.9% saline will be added to make a final volume of 1 ml- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.

Treatment:

Drug: Dexmedetomidine

midazolam group

Active Comparator group

Description:

patients will receive intranasal midazolam (0.2 mg/kg) up to 5 mg - Intranasal midazolam will be prepared from a 5 mg/ml parenteral preparation, and 0.9% saline will be added to make a final volume of one ml in a 1-ml syringe- (0.5 ml will be administrated in each nostril) before starting the anesthesia with monitoring of sedation level and oxygen saturation.

Treatment:

Drug: Midazolam