None listed
Conditions
Interventions
B:intranasal dexmedetomidine 1.5µg/kg combined with oral midazolam 0.5mg/kg
A:intranasal dexmedetomidine 1.0µg/kg combined with oral midazolam 0.5mg/kg
Sponsors
Chengdu Women and Children Central Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 3 Years
Inclusion criteria
Inclusion criteria: 1. Children aged from 12 months to 36 months who underwent MRI examination; 2. ASA Class I - II; 3. MRI scanning time is expected to be within 1 hour; 4. The legal guardian of the child has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Children aged 37.5 ?); 3. Allergies or contraindications to the test drug or syrup; 4. The child has heart conduction system disease (for example, 2 degree atrioventricular block); 5. The child received digoxin or beta receptor inhibitor treatment within 48 hours of the test; 6. The child has liver or kidney dysfunction; 7. Have a history of epilepsy or nervous system disease; 8. The child had acute rhinitis (runny nose, rhinorrhea) or upper respiratory tract infection symptoms on the day of the experiment (potential risk of interfering with nasal absorption); 9. The child has received other sedatives within 48 hours.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with UMSS score =2 and successful completion of examination within 30 minutes after the first medication and sedation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time between medication and until UMSS score =2;The time between after the examination and leaving the sedation center when meet the exit criteria;Vital signs including heart rate (HR), oxygen saturation (SpO2) and non-invasive blood pressure are noted before sedation and every 10 minutes after drug administration until meeting the exit criteria (UMSS=1 point and Aldrete score =9 points);Sedation and behavior scores were recorded at baseline and at intervals of 10min after drug administration until meeting exit criteria (UMSS=1 and Aldrete =9) ;physical activity score of each group;successful cases and sedation success rate after first sedation remediation;incidence of hypotension, bradycardia, hyperactivity, irritability, nausea and vomiting, delay in wake up (not awake for 60 minutes after MRI examination), and respiratory complications (including oxygen supply);the incidence of adverse events during follow-up; | — |
Countries
China
Contacts
Public ContactXu Li
Chengdu Women and Children Central Hospital
Outcome results
None listed