A single-arm clinical study on the efficacy and safety of buccal mucosa administration of midazolam (Buccolam Oromucosal Solution) as a premedication for dental treatment under general anesthesia in pediatric patients

Ito Takaya0 个研究点目标入组 50 人开始时间: 2024年2月1日最近更新: 2024年5月27日

试验速览

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•1) Patients scheduled for dental treatment under general anesthesia
•2) Patients who are at least 1 year old and less than 10 years old at the time of consent
•3) Patients with ASA classification 1
•4) Patients with Frankl behavior rating scale 1 or 2 (low cooperativeness for dental treatment)
•5) Patients with Mallampati scale 1 or 2 (low risk of upper airway obstruction)
•6) Brodsky tonsillar size scoring 0, 1 or 2 (no evidence of tonsillar hypertrophy)
•7) Patients with parental consent for participation in the study.
•However, for patients aged 7 years and older, written consent based on an assent document should be obtained from the patient him/herself.

•1) Patients allergic to midazolam or with a history of hypotension with midazolam
•2) Patients with psychiatric disorders
•3) Patients with respiratory disease
•4) Patients at risk of upper airway obstruction such as small jaw, adenoids, or enlarged palatine tonsils
•5) Patients with cold symptoms within 2 weeks prior to the scheduled surgery
•6) Patients who are taking cytochrome P4503A (CYP3A) inducers or inhibitors, and who will have difficulty with withdrawal of these drugs when participating in this study.
•7) Patients with myasthenia gravis
•8) Patients with acute angle-closure glaucoma
•9) Other patients who are deemed inappropriate to participate in the study by the principal investigator (subinvestigator).

发起方

Ito Takaya