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

NCT03635398 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2018-08-17

No results posted yet for this study

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

Conditions

  • Procedural Sedation
  • Intra-nasal Delevery Device

Interventions

DEVICE

Sipnose device

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

DEVICE

MAD (Mucosal Atomization Device)

MAD (Mucosal Atomization Device)

DRUG

midazolam

oral administration of midazolam

Sponsors & Collaborators

  • SipNose

    collaborator UNKNOWN

  • Rabin Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635398 on ClinicalTrials.gov