Skip to main content
OpenTrials
Completed

NCT Number: NCT04608734

Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Patients

Purpose of this study was to assess the efficacy of aerosolized midazolam, introduced through buccal versus intranasal mucosa in managing uncooperative children undergoing dental treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dental Anxiety

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

About this study

Thirty six children fulfilling the requirements of having a dental condition that needed treatment in two dental settings, not exceeding thirty minutes each. They were randomly assigned to one of two groups, according to the treatment offered at the first visit. At the first visit, either buccal or intranasal aerosolized midazolam was administered. At the second visit the alternate route was implemented in a cross-over design with a one week washout period. Vital signs were recorded at baseline and at 5 minutes interval throughout the treatment session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Negative and definitely negative behavior according Frankl's scale.
  • ASA Group I (normal healthy patient without systemic disease) and II (patient with mild systemic disease) with no medical contraindication which rules out the use of midazolam.
  • Children with at least two carious lesions requiring dental intervention in two settings of not more than 30 minute each.

Exclusion criteria

  • Children with multiple carious lesions who require treatment under general anesthesia.

Treatment and study plan

Buccal midazolam

Drug

The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.

Intranasal midazolam

Drug

Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.

Primary outcomes

  1. Acceptance of drug administration

    Time frame: during the sedation procedure

    Assessed by a 3 point Likert scale as follows: (1) the child accepted the drug readily. 2 (fair) the child accepted the drug with some resistance. 3 (poor) the child accepted the drug with great resistance. 4 (refused) the child refused but drug administration was possible after persuasion.

  2. Sleep score

    Time frame: after 5 minutes

    This will be assessed using modified Houpt scale for behavior rating:

    • Awake, alert.
    • Drowsy, disoriented.
    • Intermittently asleep.
    • Sound asleep.

  3. Crying score

    Time frame: after 5 minutes

    This will be assessed using modified Houpt scale for behavior rating:

    • Hysterical, demands attention.
    • Continuous, making treatment difficult.
    • Intermittent, mild, does not interfere with treatment.
    • No crying present.

  4. Head/oral resistance score

    Time frame: after 5 minutes

    This will be assessed using modified Houpt scale for behavior rating:

    • Turns head, refuses to open mouth.
    • Mouth closing, must request to open.
    • Chocking, gagging, spitting.
    • No head/oral resistance present.

  5. Overall behavior

    Time frame: immediately after completion of the dental treatment procedures

    This will be assessed using modified Houpt scale for behavior rating:

    • Aborted, no treatment performed.
    • Very poor, treatment interrupted, partial treatment completed.
    • Fair, difficult, all treatment completed.
    • Good, some limited crying or movement.
    • Excellent, no crying or movement.

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Collaborators

  • Alexandria University

Registry information

Official study title

Efficacy of Buccal Versus Intranasal Route of Administration of Midazolam Spray in Behavior Management of Pre-School Dental Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 29, 2020
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.