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

Nourhan M.Aly36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Dental Anxiety

Interventions

Buccal midazolamDRUG

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 midazolamDRUG

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Acceptance of drug administration

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.

Time frame: during the sedation procedure

Sleep score

This will be assessed using modified Houpt scale for behavior rating: 1. Awake, alert. 2. Drowsy, disoriented. 3. Intermittently asleep. 4. Sound asleep.

Time frame: after 5 minutes

Crying score

This will be assessed using modified Houpt scale for behavior rating: 1. Hysterical, demands attention. 2. Continuous, making treatment difficult. 3. Intermittent, mild, does not interfere with treatment. 4. No crying present.

Time frame: after 5 minutes

Head/oral resistance score

This will be assessed using modified Houpt scale for behavior rating: 1. Turns head, refuses to open mouth. 2. Mouth closing, must request to open. 3. Chocking, gagging, spitting. 4. No head/oral resistance present.

Time frame: after 5 minutes

Overall behavior

This will be assessed using modified Houpt scale for behavior rating: 1. Aborted, no treatment performed. 2. Very poor, treatment interrupted, partial treatment completed. 3. Fair, difficult, all treatment completed. 4. Good, some limited crying or movement. 5. Excellent, no crying or movement.

Time frame: immediately after completion of the dental treatment procedures

Data from ClinicalTrials.gov

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