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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03635398

Enrollment

300

Registered

2018-08-17

Start date

2018-08-31

Completion date

2020-07-31

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intra-nasal Delevery Device, Procedural Sedation

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

Interventions

DEVICESipnose device

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

DEVICEMAD (Mucosal Atomization Device)

MAD (Mucosal Atomization Device)

DRUGmidazolam

oral administration of midazolam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Anexiety level	within 60 minute	measured by modified PREOPERATIVE ANXIETY SCALE (YALE)
Sedation level	within 60 minute	measured by RAMSAY SEDATION SCALE

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026