Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Sponsor
Hadassah Medical Organization (Other)
Overall Status
Completed
CT.gov ID
NCT02679781
Collaborator
(none)
70
1
2
44.6
1.6

Study Details

Study Description

Brief Summary

The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure:

  1. acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.
Condition or Disease Intervention/Treatment Phase
  • Drug: oral midazolam
  • Drug: nasal midazolam
N/A

Detailed Description

  • Prospective, parallel design

  • Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =

75% airway obstruction), upper respiratory tract infection or nasal discharge.

  • Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam;

  • Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

  • Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered).

  • Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
Actual Study Start Date :
Mar 28, 2017
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: oral sedation

administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

Drug: oral midazolam
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Other Names:
  • oral dormicum
  • Active Comparator: nasal sedation

    administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.

    Drug: nasal midazolam
    administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
    Other Names:
  • nasal dormicum
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants Compliant With Oral or Nasal Midazolam Administration [the compliance in taking the medication will be assessed at the time of administration and recorded immediately.]

      the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).

    Secondary Outcome Measures

    1. Behavior During Dental Treatment [the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.]

      the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. = Aborted, no treatment rendered. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.
    Exclusion Criteria:
    • enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =

    75% airway obstruction), upper respiratory tract infection or nasal discharge.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hadassah Medical Organization Jerusalem Israel 91120

    Sponsors and Collaborators

    • Hadassah Medical Organization

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Avia Fux, pediatric dentist, Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT02679781
    Other Study ID Numbers:
    • 0678-15-HMO-CTIL
    First Posted:
    Feb 10, 2016
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Oral Sedation Nasal Sedation
    Arm/Group Description administration of 0.5mg/kg oral midazolam. administration of 0.2mg/kg nasal midazolam.
    Period Title: Overall Study
    STARTED 37 33
    COMPLETED 30 30
    NOT COMPLETED 7 3

    Baseline Characteristics

    Arm/Group Title Oral Sedation Nasal Sedation Total
    Arm/Group Description administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. Total of all reporting groups
    Overall Participants 30 30 60
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    4.25
    (1.39)
    4.46
    (1.25)
    4.36
    (1.32)
    Sex: Female, Male (Count of Participants)
    Female
    15
    50%
    14
    46.7%
    29
    48.3%
    Male
    15
    50%
    16
    53.3%
    31
    51.7%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (participants) [Number]
    Israel
    30
    100%
    30
    100%
    60
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Participants Compliant With Oral or Nasal Midazolam Administration
    Description the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).
    Time Frame the compliance in taking the medication will be assessed at the time of administration and recorded immediately.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Oral Sedation Nasal Sedation
    Arm/Group Description administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
    Measure Participants 30 30
    willingly
    11
    36.7%
    4
    13.3%
    coaxed
    14
    46.7%
    18
    60%
    forced
    5
    16.7%
    8
    26.7%
    2. Secondary Outcome
    Title Behavior During Dental Treatment
    Description the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. = Aborted, no treatment rendered. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement
    Time Frame the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Oral Sedation Nasal Sedation
    Arm/Group Description administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
    Measure Participants 30 30
    Mean (Standard Deviation) [score on a scale]
    5.17
    (0.79)
    4.80
    (0.80)

    Adverse Events

    Time Frame From administering the medication until recovery from sedation- at least 2 hours for each patient
    Adverse Event Reporting Description
    Arm/Group Title Oral Sedation Nasal Sedation
    Arm/Group Description administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
    All Cause Mortality
    Oral Sedation Nasal Sedation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/33 (0%)
    Serious Adverse Events
    Oral Sedation Nasal Sedation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/33 (0%)
    Other (Not Including Serious) Adverse Events
    Oral Sedation Nasal Sedation
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/37 (0%) 0/33 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Avia Fux-Noy
    Organization Hadassah School of Dental Medicine, P.O.Box 12272
    Phone +97226776135
    Email fuxavia@gmail.com
    Responsible Party:
    Avia Fux, pediatric dentist, Hadassah Medical Organization
    ClinicalTrials.gov Identifier:
    NCT02679781
    Other Study ID Numbers:
    • 0678-15-HMO-CTIL
    First Posted:
    Feb 10, 2016
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Jan 1, 2022