Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alexandria University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buccal midazolam | Experimental |
| |
| Intranasal midazolam | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| after 5 minutes |
| Crying score | This will be assessed using modified Houpt scale for behavior rating:
| after 5 minutes |
| Head/oral resistance score | This will be assessed using modified Houpt scale for behavior rating:
| after 5 minutes |
| Overall behavior | This will be assessed using modified Houpt scale for behavior rating:
| immediately after completion of the dental treatment procedures |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yousr N Mowafy, M.Sc | Faculty of Dentistry, Alexandria University, Egypt | Principal Investigator |
| Nadia A Wahba, PhD | Faculty of Dentistry, Alexandria University, Egypt | Study Director |
| Tamer M Ghoneim, PhD | Faculty of Medicine, Alexandria University, Egypt | Study Chair |
| Ghada M Mahmoud, PhD | Faculty of Dentistry, University of Modern Sciences and Arts, Egypt. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21512 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24357534 | Background | Chopra R, Marwaha M. Assessment of buccal aerosolized midazolam for pediatric conscious sedation. J Investig Clin Dent. 2015 Feb;6(1):40-4. doi: 10.1111/jicd.12062. Epub 2013 Dec 20. | |
| 11309871 | Background | al-Rakaf H, Bello LL, Turkustani A, Adenubi JO. Intra-nasal midazolam in conscious sedation of young paediatric dental patients. Int J Paediatr Dent. 2001 Jan;11(1):33-40. doi: 10.1046/j.1365-263x.2001.00237.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 8247896 | Background | Kupietzky A, Houpt MI. Midazolam: a review of its use for conscious sedation of children. Pediatr Dent. 1993 Jul-Aug;15(4):237-41. No abstract available. |
| 8668567 | Background | Kupietzky A, Holan G, Shapira J. Intranasal midazolam better at effecting amnesia after sedation than oral hydroxyzine: a pilot study. Pediatr Dent. 1996 Jan-Feb;18(1):32-4. |
| 16435641 | Background | Primosch RE, Guelmann M. Comparison of drops versus spray administration of intranasal midazolam in two- and three-year-old children for dental sedation. Pediatr Dent. 2005 Sep-Oct;27(5):401-8. |
| 3857559 | Background | Houpt MI, Weiss NJ, Koenigsberg SR, Desjardins PJ. Comparison of chloral hydrate with and without promethazine in the sedation of young children. Pediatr Dent. 1985 Mar;7(1):41-6. No abstract available. |