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

Shanghai Hengrui Pharmaceutical Co., Ltd.159 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

159

Conditions

Preoperative Sedation of Children

Interventions

Dexmedetomidine Hydrochloride Nasal SprayDRUG

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.

Dexmedetomidine hydrochloride nasal spray blank preparationDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Male or female 3. Subjects requiring elective general anesthesia surgery 4. Conform to the ASA Physical Status Classification 5. Meet the weight standard Exclusion Criteria: 1. Not suitable for nasal spray 2. Pediatric populations requiring special care or court/social welfare supervision 3. Subjects who had been under general anesthesia when they were randomized 4. Subjects with a history of mental illness and a history of cognitive impairment epilepsy 5. Subjects with cardiovascular disease 6. Subjects whose hemoglobin is below the lower limit of normal 7. Subjects with a history or possibility of a difficult airway 8. Abnormal liver function and/or abnormal renal function 9. Adrenoceptor agonists or antagonists or analgesics were used before randomization 10. Participated in clinical trials (received experimental drugs) 11. History of hypersensitivity to drug ingredients or components 12. Other circumstances that the investigator judged inappropriate for participation in this clinical trial

Locations (1)

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Proportion of subjects who meet parent-child separation successful

Time frame: 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

Time frame: within 45 minutes after the beginning of administration

Secondary Outcomes

Proportion of subjects who meet parent-child separation successful within 45 minutes after the beginning of administration

The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item.

Time frame: Within 45 minutes after the beginning of administration

Time from the beginning of administration to the successful parent-child separation for the first time through study completion，an average of 3 days

The FUNK scale is a scale of 1 to 4 for sedation, anxiety, and separation from parents. Separation success is defined as a scale of 3 or 4 per item.

Time frame: an average of 3 days

Proportion of subjects whose the Ramsay score is satisfactory at least once within 45 minutes after the beginning of administration

Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.

Time frame: Within 45 minutes after the beginning of administration

Time from the beginning of administration to the satisfactory Ramsay score for the first time

Sedation level using the Ramsay scale. Ramsay Satisfaction is defined as a scale of ≥ 3.

Time frame: from the beginning of administration to the first successful Ramsay score

Data from ClinicalTrials.gov

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