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

JRCT ID: jRCTs031230610

Registered date:01/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pediatric patient undergoing dental treatment under general anesthesia
• Date of first enrollment: 01/03/2024
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Midazolam administered buccally as a premedication for dental treatment under general anesthesia

Outcome(s)

• Primary Outcome: Percentage of patients with a Mask Acceptance Scale (4-point scale) of 1 or 2 at 20 minutes after buccal administration of midazolam

Secondary Outcome

1) Percentage of patients with a Ramsay Sedation Score (6-point scale of sedation after midazolam buccal administration) of 2 to 6 at 20 minutes after midazolam administration.
2) Percentage of patients with a Parental Separation Anxiety Scale (4-point scale of calmness of the child) of 1 or 2 at 20 minutes after midazolam buccal administration.

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: < 10age old
• Gender: Both

Include 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.

Exclude 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).

Related Information

• Primary Sponsor: Ito Takaya