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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

Tracking Information
First Submitted Date  ICMJE March 31, 2015
First Posted Date  ICMJE April 3, 2015
Last Update Posted Date April 9, 2015
Study Start Date  ICMJE April 2015
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
  • time until sedation is achieved [ Time Frame: 1 hour ]
  • duration of sedation [ Time Frame: 4 hour ]
    time from achieving sedation until reaching full consciousness
  • convenience of administration [ Time Frame: 15 minutes ]
    described by the parent and the physician by a numerical rating scale (NRS) questionaire
  • efficacy of the sedation [ Time Frame: 4 hours ]
    described by the parent, nurse and physician by a NRS questionaire
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
  • time until sedation is achieved [ Time Frame: 1 hour ]
  • duration of sedation [ Time Frame: 4 hour ]
    time from achieving sedation until reaching full consciousness
  • convenience of administration [ Time Frame: 15 minutes ]
    described by the parent and the physician
  • efficacy of the sedation [ Time Frame: 4 hours ]
    described by the parent, nurse and physician
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children
Official Title  ICMJE Buccal Midazolam Versus Nasal or Oral Midazolam Sedation for Minor Invasive Procedures in Children: A Prospective Randomized Control Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Dormicum
  • Conscious Sedation
  • Children
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: oral midazolam
    oral midazolam 0.5-0.7 mg/kg maximum 10 mg. one dose only before the invasive procedure.
    Intervention: Drug: Midazolam
  • Active Comparator: intranasal midazolam
    intranasal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
    Intervention: Drug: Midazolam
  • Active Comparator: buccal midazolam
    buccal midazolam 0.3-0.5 mg/kg maximum 5 mg. one dose only before the invasive procedure
    Intervention: Drug: Midazolam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 2, 2015)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02408302
Other Study ID Numbers  ICMJE CMC-13-0075-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Muriel Konopnicki, Carmel Medical Center
Study Sponsor  ICMJE Carmel Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Muriel Konopnicki Carmal Medical Center, Haifa, Israel
PRS Account Carmel Medical Center
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP