The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorGuangzhou Novaken Pharm Co., Ltd.

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

Eligibility criteria

Qualifiers

Aged 2 years to 6 years (inclusive ), any genders;

Scheduled to undergo general anesthesia for surgery/procedure

American Society of Anesthesiologists(ASA) I~II

Provide written informed consent from the legal guardian

Disqualifiers

Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;

Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;

History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;

History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;

Trial design

Treatments tested in this trial

  • Dexmedetomidine hydrochloride Microneedles
  • Dexmedetomidine hydrochloride Microneedles
  • placebo
  • Dexmedetomidine hydrochloride Microneedles
  • Placebo

Treatment groups

64 Participants
are divided into 3 treatment groups