Intranasal dexmedetomidine for premedication

The feasibility analyses of intranasal dexmedetomidine for premedication in pediatric patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs061200032

Enrollment

Registered

2020-12-01

Start date

2021-01-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Developmental disoirders, Intellectual disability, Autism

Interventions

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

D008874, D000284, D020927, D00028, D011292

Midazolam, dexmedetomidine, premedication

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Contacts

Public ContactHitoshi Higuchi

Okayama Univesity Hospital

higuti@md.okayama-u.ac.jp+81-86-235-6721

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026