A Phase 2 interventional study of Midazolam group (MDZ) and Dexmedetomidine group (DEX) in Dental Anxiety, sponsored by Nourhan M.Aly. Completed at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2020-01-22.
Sponsored by Nourhan M.Aly · Phase 2, Interventional, and Other
The aim of the study is to evaluate the effect of nebulized Midazolam, Dexmedetomidine, and their combination as procedural, moderate sedative agents in preschoolers undergoing dental treatment.
Dental anxiety and fear related behaviors are global problems in Pediatric Dentistry. Preschoolers represent a dental behavior management problem and there is always a debate over the best behavioral management technique for preschoolers undergoing dental treatment. Moderate sedation is considered as an acceptable option.
Children who need treatment under local anesthesia, for thirty minutes will be included in the study. A total of 72 uncooperative pediatric dental patients, of age range 4-6 years, will be selected from the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The participants will be randomly allocated into 3 groups that will undergo a procedural sedation session via a nebulizer. Children of group I will receive nebulized solution of 0.5 mg/kg Midazolam, Group II will receive nebulized solution of 5µg/kg Dexmedetomidine, and Group III will receive a nebulized solution of 0.3 mg/kg Midazolam and 3µg/kg Dexmedetomidine respectively.
Nourhan M.Aly is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.5 mg/kg Midazolam.
Drug: Midazolam group (MDZ)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 5µg/kg Dexmedetomidine.
Drug: Dexmedetomidine group (DEX)
Twenty four pediatric dental patients will receive a procedural sedation session, using Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.
Drug: Combination of Midazolam and Dexmedetomidine (MDZ/DEX)
IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
Facemask acceptance during drug delivery
It will be evaluated according to Zanaty \& Metainy as: poor (terrified, crying and combative), fair (moderate fear of mask not calmed with reassurance), good (slight fear of mask, easily reassured) or excellent (unafraid, cooperative and accepts mask readily)
Time frame: during the sedation procedure
Effect of sedation on children's future behavior
Each child's behavior will be reassessed in the follow-up sessions and compared to that at baseline (before dental treatment) using Frankl scale (ranges from 0-4)
Time frame: after one week in the follow-up session
The 'ease of treatment completion' sing separate five-point scales.
This will be measured using separate five-point scales according to Surendar et al: Score 5 indicates an excellent quiet and cooperative child while score 1 indicates Prohibitive active resistance and crying; treatment cannot be rendered.
Time frame: immediately after completion of the dental treatment procedures.
Post-operative effects of the sedation
This will be assessed according to Modified Vernon et al.
Time frame: immediately after completion of the dental treatment procedures.
Analgo-sedative effect of each drug
Onset of Sedation from drug administration until the onset of satisfactory sedation
Time frame: during the sedation procedure (time taken from drug administration till reaching satisfactory sedation)
Analgo-sedative effect of each drug
Sedation level using Modified Observer's Assessment of Alertness/Sedation Scale. The scale is composed of 4 categories (each has scores ranging from 1-5). The categories are responsiveness, speech, facial expression and eyes. The final score is the sum of scores: the totally awake score is 20/20 and the deeply sedated score is 9/20
Time frame: during the sedation procedure (after drug administration until reaching satisfactory sedation)
Analgo-sedative effect of each drug
The analgesic effect of the sedative drugs will be assessed using "Face, Legs, Activity, Cry, Consolability" scale (FLACC). The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.
Time frame: during local anesthesia injection to start the operative procedure
Analgo-sedative effect of each drug
The duration of sedation: defined as the onset of satisfactory sedation until the time of meeting discharge criteria according to the American Academy of Pediatric Dentistry.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Analgo-sedative effect of each drug.
Assessment of the most common procedural side effects such as (hypoxia, respiratory depression, agitation, arrhythmia, bradycardia, hypotension or hypertension, shivering, nausea and vomiting) will be recorded.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Amnesic effect of sedative agents.
Anterograde amnesia: will be assessed according to a modification of Bulach et al.
Time frame: immediately after completion of the dental treatment procedures.
Hemodynamic response of sedative agents.
Vital sign: Blood pressure (in mmHg) will be monitored using a sphygmomanometer.
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Vital sign: Heart rate will be counted
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
Hemodynamic response of sedative agents.
Vital sign: Oxygen saturation will be monitored using an oximeter
Time frame: during the sedation procedure (from its onset till meeting discharge criteria)
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Nourhan M.Aly