The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
Recruiting
Phase 2
Interventional Study
Preoperative Sedation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 6
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 64 (estimated)
- Sponsor
- Guangzhou Novaken Pharm Co., Ltd. · Industry
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About This Trial
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Aged 2 years to 6 years (inclusive ), any genders;
* Body weight meeting the criteria:
* Scheduled to undergo general anesthesia for surgery/procedure
* American Society of Anesthesiologists(ASA) I\~II
* Provide written informed consent from the legal guardian
Exclusion Crite…
Contacts