Intranasal dexmedetomidine for premedication

JRCT ID: jRCTs061200032

Registered date:01/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dental Caries
• Date of first enrollment: 15/01/2021
• Target sample size: 60
• Study type: Interventional

Intervention(s)

1. Oral administration of midazolam for premedication
2. Intranasal administration of dexmedetomidine for premedication

Outcome(s)

• Primary Outcome: The numbers and rates of patients who accepted oral midazolam, rejected oral midazolam but accepted nasal dexmedetomidine, rejected both of oral midazolam and nasal dexmedetomidine.

Secondary Outcome

1. Sedation Score at anesthesia induction.
2. Distress Rating Scale at anesthesia induction.
3. Time from premedication to anesthesia induction.
4. Blood pressure, pulse rate, arterial oxygen saturation, and bispectral Index values during anesthesia.
5. Occurrence of delirium at anesthesia emergence.
6. Time from anesthesia awake to home back
7. Adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 15age old
• Gender: Both

Include criteria

1. Pediatric patients under 15 years who are scheduled to undergo dental treatments under general anesthesia at the Center of the Special Needs Dentistry of Okayama University Hospital.
2. Pediatric patients who need premedication for anesthesia induction becasue of their non-cooperation.
3. Patients who exhibit an American Society of Anesthesiologists (ASA) physical status of 1 or 2.

Exclude criteria

1. Pediatric patients who have a medical history of anaphylaxis against midazolam and/or dexmedetomidine.
2. Pediatric patients who contraindicate for the use of midazolam (acute angle-closure glaucoma, myasthenia gravis, using HIV protease inhibitor, medicines including Efavirenz or Cobicistat and/or Nirmatrelvir/Ritonavir, shock, coma, and acute alcoholic intoxication with vital sign inhibitions )
3. Pediatric patients who the principal investigator or co-investigator decide to be inadequacy for participants.

Related Information

• Primary Sponsor: Higuchi Hitoshi