Efficacy and safety of buccal administration of midazolam as premedication in dental treatment under general anesthesia in pediatric patients

Phase 2

Recruiting

Conditions: Pediatric patient undergoing dental treatment under general anesthesia

Registration Number: JPRN-jRCTs031230610

Lead Sponsor: Ito Takaya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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).