CompletedPhase 3

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

China159 participantsStarted 2021-11-24

Plain-language summary

The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.

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.

✕. Not suitable for nasal spray
✕. Pediatric populations requiring special care or court/social welfare supervision
✕. Subjects who had been under general anesthesia when they were randomized
✕. Subjects with a history of mental illness and a history of cognitive impairment epilepsy
✕. Subjects with cardiovascular disease
✕. Subjects whose hemoglobin is below the lower limit of normal
✕. Subjects with a history or possibility of a difficult airway
✕. Abnormal liver function and/or abnormal renal function

Proportion of subjects who meet parent-child separation successful

Timeframe: within 45 minutes after the beginning of administration

Proportion of subjects who meet the Ramsay sedation score of 3 at least once within 45 minutes after the beginning of administration

Timeframe: within 45 minutes after the beginning of administration

NCT IDNCT05111431

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-20