Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study

Clalit Health Services

Status: Unknown

Conditions: Intra-nasal Delevery Device; Procedural Sedation

Treatments: Device: Sipnose device; Drug: midazolam; Device: MAD (Mucosal Atomization Device)

Study type: Interventional

Funder types: Other

Identifiers

NCT03635398

RMC-17-0435

Details and patient eligibility

About

A Three-arm, Randomized Controlled Trial for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety: Intranasal Midazolam by SipNose versus MAD Versus oral administration

Enrollment: 300 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• every child >1y who is intended for medical procedure in the emrgency room(suce as: IV insertion, blood sample collection, urinary catether insertion, laceration repair

Exclusion criteria

• ASA>2
• Active respiratory infection
• systemic illness
• Allergy to Midazolam

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Intranasal Midazolam by SipNose device

Experimental group

Treatment:

Device: Sipnose device

Intranasal Midazolam by MAD (Mucosal Atomization Device)

Active Comparator group

Treatment:

Device: MAD (Mucosal Atomization Device)

oral administration of midazolam

Active Comparator group

Treatment:

Drug: midazolam