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

Rabin Medical Center1 site in 1 country300 target enrollmentAugust 2018

ConditionsProcedural Sedation Intra-nasal Delevery Device

InterventionsSipnose device MAD (Mucosal Atomization Device)midazolam

Drugsmidazolam

Overview

Phase: Not Applicable
Intervention: Sipnose device
Conditions: Procedural Sedation
Sponsor: Rabin Medical Center
Enrollment: 300
Locations: 1
Primary Endpoint: Sedation level
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2018

End Date

July 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rabin Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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