Trials / Completed
CompletedNCT04200235
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexmedetomidine hydrochloride nasal spray | In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray. |
| DRUG | Dexmedetomidine hydrochloride nasal spray blank preparation. | In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. |
Timeline
- Start date
- 2020-01-06
- Primary completion
- 2020-08-06
- Completion
- 2020-08-07
- First posted
- 2019-12-16
- Last updated
- 2020-09-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04200235. Inclusion in this directory is not an endorsement.