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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Dental Anxiety

Intervention / Treatment
-----------------
* Drug: Buccal midazolam
* Drug: Intranasal midazolam


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buccal midazolam<br> | Drug: Buccal midazolam<br>* 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.<br>|
| Active Comparator: Intranasal midazolam<br> | Drug: Intranasal midazolam<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | during the sedation procedure | 
| Sleep score | This will be assessed using modified Houpt scale for behavior rating: Awake, alert. Drowsy, disoriented. Intermittently asleep. Sound asleep. | after 5 minutes | 
| Crying score | 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. | after 5 minutes | 
| Head/oral resistance score | 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. | after 5 minutes | 
| Overall behavior | 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. | immediately after completion of the dental treatment procedures |