None listed
Conditions
Interventions
Experimental Group:Dexmedetomidine Hydrochloride Nasal Spray
Dexmedetomidine hydrochloride nasal spray used in this study is produced by Jiangsu Hengrui Pharmaceutical Co., Ltd. Before administration,
Type II: 300 µg/ml, 15 µg per spray). The total dose is calculated at 2 µg/kg, and the appropriate preparation is selected for fractional spray according to the body weight. The entire administration
Control Group:Oral Chloral Hydrate Syrup
Chloral hydrate syrup combination package is produced by Nanjing Tefeng Pharmaceutical Co., Ltd., Jiangsu Province. Take chloral hydrate concentrate, draw the
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: All children must meet all the following criteria to be enrolled in the trial: 1. Aged 2 to 6 years (inclusive), regardless of gender; 2. Difficulty in cooperating with examinations on their own and requiring sedation to complete relevant outpatient examinations; 3. ASA physical status classification I or II; 4. Legal guardians of the children have signed the informed consent form.
Exclusion criteria
Exclusion criteria: Children who meet any of the following criteria will be excluded from the trial: 1. Severe rhinitis, nasal deformity and nasal mucosal damage; 2. Severe upper respiratory tract infection; 3. Cardiac arrhythmia, especially chronic arrhythmia; 4. Hepatic and renal insufficiency; 5. A history of hypersensitivity to sedative drugs; 6. General anesthesia within 2 weeks; 7. Use of sedative-hypnotic drugs (including benzodiazepines such as diazepam and barbiturates such as phenobarbital) within 1 week; 8. Mental system diseases and cognitive dysfunction; 9. Severe obesity (body weight = 50% higher than the standard body weight); 10. Loss to follow-up; 11. Other circumstances deemed unsuitable for participation in this clinical trial by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rescue sedation success rate;Onset time of sedation;Duration of sedation;Failure rate of diagnostic and therapeutic procedures;Delayed recovery rate; | — |
Countries
China
Contacts
Public ContactLei Xiaoping
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed