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Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children

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: NCT02408302
Recruitment Status : Unknown
Verified March 2015 by Muriel Konopnicki, Carmel Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 3, 2015
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Muriel Konopnicki, Carmel Medical Center

Brief Summary:

Currently Midazolam sedation is the standard of care for minor invasive procedures in pediatric patients; its use is restricted to two routes of administration for this purpose oral and intranasal.

A third route of administration (buccal) is tested and approved for seizure management. In the investigators' study the researchers investigate the buccal route of administration versus oral or intranasal administration for sedation. The investigators' hypothesis is that buccal route of administration is more convenient than intranasal and better absorbed than oral.


Condition or disease Intervention/treatment Phase
Dormicum Conscious Sedation Children Drug: Midazolam Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study
Study Start Date : April 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: oral midazolam
oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
Drug: Midazolam
comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.
Other Name: Dormicum

Active Comparator: intranasal midazolam
intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
Drug: Midazolam
comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.
Other Name: Dormicum

Active Comparator: buccal midazolam
buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
Drug: Midazolam
comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.
Other Name: Dormicum




Primary Outcome Measures :
  1. time until sedation is achieved [ Time Frame: 1 hour ]
  2. duration of sedation [ Time Frame: 4 hour ]
    time from achieving sedation until reaching full consciousness

  3. convenience of administration [ Time Frame: 15 minutes ]
    described by the parent and the physician by a numerical rating scale (NRS) questionaire

  4. efficacy of the sedation [ Time Frame: 4 hours ]
    described by the parent, nurse and physician by a NRS questionaire



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 5 months to 6 years.
  • need to undergo a minimal invasive procedure that requires light sedation.
  • ASA (American Society of Anesthesiologists) I-II
  • parent that can read, understand and sign an informed consent form

Exclusion Criteria:

  • patients with life threatening conditions.
  • patients with respiratory or cardiac chronic illnesses or ASA other than I-II.
  • patients with traumatic injury for the nose or the oral cavity.
  • patients that would not or cannot take the drug in the route picked in a randomized way.

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): NCT02408302


Contacts
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Contact: Muriel Konopnicki 972-4-8250240 MurielKo2@clalit.org.il

Locations
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Israel
Carmel Medical Center
Haifa, Israel
Contact: Muriel Konopnicki, MD    972-4-8250240    MurielKo2@clalit.org.il   
Principal Investigator: Muriel Konopnicki, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
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Principal Investigator: Muriel Konopnicki Carmal Medical Center, Haifa, Israel
Publications:

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Responsible Party: Muriel Konopnicki, Head of Pediatric emergency room, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02408302    
Other Study ID Numbers: CMC-13-0075-CTIL
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 9, 2015
Last Verified: March 2015
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