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

Phase 2

Completed

• Conditions: Dental Anxiety
• Interventions: Drug: Buccal midazolam; Drug: Intranasal midazolam

• Registration Number: NCT04608734
• Lead Sponsor: Nourhan M.Aly

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.

Study Timeline

• Study Start: 2015-06-10
• Primary Completion: 2016-06-13
• Study Completion: 2016-06-25
• Status Verified: 2020-10
• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Last Update Submitted: 2020-10-24
• Study First Posted: 2020-10-29
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Buccal midazolam	Buccal midazolam	-
Intranasal midazolam	Intranasal midazolam	-

Primary Outcome Measures

Name	Time	Method
Sleep score	after 5 minutes	This will be assessed using modified Houpt scale for behavior rating: 1. Awake, alert.; 2. Drowsy, disoriented.; 3. Intermittently asleep.; 4. Sound asleep.
Crying score	after 5 minutes	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.
Head/oral resistance score	after 5 minutes	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.
Overall behavior	immediately after completion of the dental treatment procedures	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.
Acceptance of drug administration	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt