Trials / Completed
CompletedNCT05111431
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
Study on Efficacy and Safety of Dexmedetomidine Hydrochloride Nasal Spray for Preoperative Sedation in Children
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 2 Years – 6 Years
- Healthy volunteers
- Not accepted
Summary
The study is being conducted to evaluate the efficacy, and safety 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, the subjects will receive a low dose of dexmedetomidine nasal spray. In the high weight group, the subjects will receive a high dose of dexmedetomidine nasal spray. |
| DRUG | Dexmedetomidine hydrochloride nasal spray blank preparation | In the low weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. In the high weight group, the subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation. |
Timeline
- Start date
- 2021-11-24
- Primary completion
- 2022-05-20
- Completion
- 2022-05-20
- First posted
- 2021-11-08
- Last updated
- 2022-11-07
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05111431. Inclusion in this directory is not an endorsement.