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

Nourhan M.Aly

Status and phase

Completed

Phase 2

Conditions

Dental Anxiety

Treatments

Drug: Buccal midazolam

Drug: Intranasal midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT04608734

Buccal vs intranasal midazolam

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

3 to 5 years old

Volunteers

No Healthy Volunteers

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