CompletedPhase 1

A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children

China48 participantsStarted 2020-01-06

Plain-language 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

Who can participate

Age range2 Years – 6 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Able and willing to provide a written informed consent
✓. Male or female
✓. Subjects requiring elective general anesthesia surgery
✓. Conform to the ASA Physical Status Classification
✓. Meet the weight standard

Exclusion criteria

✕. Not suitable for nasal spray
✕. Pediatric populations requiring special care or court/social welfare supervision
✕. Subjects who had been under general anesthesia were randomized
✕. Subjects with mental disorders and cognitive impairment；Subject with a history of epilepsy
✕. Subjects with previous abnormal behavior after medication
✕. Subjects with cardiovascular disease
✕. Clinically significant abnormal clinical laboratory test value
✕. Subjects whose hemoglobin is below the lower limit of normal

What they're measuring

PK Cmax

Timeframe: 0 to 1 hour after administration

Trial details

NCT IDNCT04200235

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-08-06

View on ClinicalTrials.gov More Preoperative Sedation trials