臨床研究等提出・公開システム

The feasibility analyses of intranasal dexmedetomidine for premedication in pediatric patients

Intranasal dexmedetomidine for premedication

Higuchi Hitoshi

Okayama Unisersity Hospital

2-5-1 Shikara-cho, Kita-ku, Okayama

higuti@md.okayama-u.ac.jp

Higuchi Hitoshi

Okayama Univesity Hospital

2-5-1 Shikara-cho, Kita-ku, Okayama

+81-86-235-6721

higuti@md.okayama-u.ac.jp

Not Recruiting

Dec. 01, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Both

Dental Caries

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

Developmental disoirders, Intellectual disability, Autism

Midazolam, dexmedetomidine, premedication

D003731

D008874, D000284, D020927, D00028, D011292

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.

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

+81-86-235-7133

Oct. 29, 2020

None