A Phase 2 interventional study of Buccal midazolam and Intranasal midazolam in Dental Anxiety, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 3 Years to 5 Years. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by Nourhan M.Aly · Phase 2, Interventional, and Treatment
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.
Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Buccal midazolam
Drug: Intranasal midazolam
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.
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.
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
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Nourhan M.Aly