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

Rabin Medical Center300 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Procedural Sedation Intra-nasal Delevery Device

Interventions

Sipnose deviceDEVICE

SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety

MAD (Mucosal Atomization Device)DEVICE

MAD (Mucosal Atomization Device)

midazolamDRUG

oral administration of midazolam

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

Outcomes

Primary Outcomes

Anexiety level

measured by modified PREOPERATIVE ANXIETY SCALE (YALE)

Time frame: within 60 minute

Sedation level

measured by RAMSAY SEDATION SCALE

Time frame: within 60 minute

Data from ClinicalTrials.gov

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