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The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Hydrochloride Nasal Spray | Experimental |
| |
| Dexmedetomidine hydrochloride nasal spray blank preparation | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Nasal Spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who meet parent-child separation successful | 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 | within 45 minutes after the beginning of administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 45 minutes after the beginning of administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | 100045 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39242499 | Derived | Gao J, Wang F, Wang X, Zou X, Liu HC, Song X, Chai X, Jiang R, Zhao P, Zhang J, Wang SY, Ma H, Zhao Z, Wang Q, Zhou N, Bai J, Zhang J. Safety and efficacy of a novel dexmedetomidine nasal spray for pre-anesthetic sedation in children: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2024 Sep 6;24(1):315. doi: 10.1186/s12871-024-02708-1. |
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Dexmedetomidine hydrochloride nasal spray compared with placebo
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| Dexmedetomidine hydrochloride nasal spray blank preparation | Drug | 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. |
|
| 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. |
| 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. | 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. | from the beginning of administration to the first successful Ramsay score |
| Proportion of subjects whose the UMSS Scale is satisfactory at least once within 45 minutes after the beginning of administration | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2 . | within 45 minutes after the beginning of administration |
| Time from the beginning of administration to the satisfactory UMSS score for the first time through study completion，an average of 3 days | Sedation level using the University of Michigan Sedation Scale. UMSS satisfaction is defined as a scale of ≥ 2. | an average of 3 days |
| Time of anesthesia awakening through study completion，an average of 3 days | an average of 3 days |