Master of Science (M.S.) in Dentistry
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College of Dental Medicine
Publication Date / Copyright Date
Nova Southeastern University
Marisol Carbonell. 2019. Likability and Efficacy of Gummy Oral Sedative by Pediatric Patients. Master's thesis. Nova Southeastern University. Retrieved from NSUWorks, College of Dental Medicine. (76)
Background: Behavior guidance of the pediatric patient remains a challenge in dentistry and may require pharmaceutical interventions. Midazolam and hydroxyzine oral syrups are predictable and frequently used for in-office sedations in pediatric dentistry. However, midazolam’s bitter taste and hydroxyzine’s large volume make administration problematic for uncooperative children. The purpose of this project was to compare the use of soft-chewable gummies containing sedatives to the oral syrups currently used in conscious sedation. The aim of this project was to administer midazolam and hydroxyzine in gummy form and determine if this alternative vessel is as effective and better liked by children undergoing sedation when compared to the respective oral syrups. Methods: Small-sized gummies containing 2.5 mg of midazolam or 5.0 mg of hydroxyzine were optimized for taste masking and compounded at the NSU pharmacy. A pilot study was conducted at NSU’s Joe DiMaggio Dental Clinic to test the likability and the effectiveness of these gummies. A convenience sample of 20 patients requiring conscious sedation were evaluated and determined eligible to receive sedation by gummies for the test group. A cohort of 20 patients previously administered syrup sedatives served as the historical control. In both groups, the sedative agent and dose were selected and calculated based on patient specific parameters and anticipated duration of treatment. Sedation onset time was recorded for each patient along with a score obtained from a hedonic scale evaluating patients’ likability of the different medications. Results: For the midazolam group, data obtained from the historic cohort, was compared to the data obtained from the participants of the clinical trial. A small sample size did not allow for categorizing patients based on demographics, however there were no significant differences between both groups. The midazolam gummy group had a greater frequency of higher hedonic scale scores, however, the finding was not statistically significant. The onset time for the midazolam gummy group was also slightly shorter, but also not statistically significant. Results for the midazolam and hydroxyzine group are not available due to insufficient data and low number of participants. Conclusions: Oral sedation is an alternative method of behavior guidance used by pediatric dentists. The targeted population often rejects the medication, compromising the sedation. More favorable methods of administering medications are necessary. Research using compounded medications and clinical trials with the pediatric population must continue to optimize the final product.
Compounding, Gummy, Hydroxyzine, Midazolam, Oral Conscious sedation, Pediatrics
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