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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03635398
Recruitment Status : Unknown
Verified August 2018 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
Sponsor:
Collaborator:
SipNose
Information provided by (Responsible Party):
Rabin Medical Center

Study Description
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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

Condition or disease Intervention/treatment Phase
Procedural Sedation Intra-nasal Delevery Device Device: Sipnose device Device: MAD (Mucosal Atomization Device) Drug: midazolam Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intranasal Midazolam for Pediatric Pre-procedural Sedation and Pre-procedural Anti-anxiety Using sipNose Device - a Randomized Controlled Study
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intranasal Midazolam by SipNose device Device: Sipnose device
SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
Active Comparator: Intranasal Midazolam by MAD (Mucosal Atomization Device) Device: MAD (Mucosal Atomization Device)
MAD (Mucosal Atomization Device)
Active Comparator: oral administration of midazolam Drug: midazolam
oral administration of midazolam


Outcome Measures
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Primary Outcome Measures :
  1. Anexiety level [ Time Frame: within 60 minute ]
    measured by modified PREOPERATIVE ANXIETY SCALE (YALE)

  2. Sedation level [ Time Frame: within 60 minute ]
    measured by RAMSAY SEDATION SCALE


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • ASA>2
  • Active respiratory infection
  • systemic illness
  • Allergy to Midazolam
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635398


Locations
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Israel
Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 49202
Sponsors and Collaborators
Rabin Medical Center
SipNose
More Information
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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03635398    
Other Study ID Numbers: RMC-17-0435
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because of commercial confidentially the study database will not become public within the first 3 years since the begining of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action