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The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.
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Prospective, parallel design Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = >75% airway obstruction), upper respiratory tract infection or nasal discharge. Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam; Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered). Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.
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70 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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