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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06085573 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
This study is seeking for children who are 1 month to less than 18 years old.
The patients are planned to be looked over:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine Hydrochloride | Pediatric patients (1 month to < 18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation of non-intubated pediatric patients for non-invasive procedures and tests" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine Hydrochloride | Drug | <Sedation of non-invasive procedures and tests without intubation in pediatrics> For children aged 2 years or older, the usual dosage of dexmedetomidine is 12 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). For children aged 1 month to < 2 years old, the usual dosage of dexmedetomidine is 9 μg/kg/hr given as a continuous intravenous infusion over 10 minutes (initial loading dose) followed by a maintenance dose of 1.5 μg/kg/hr (maintenance dose). The infusion rate should be reduced according to patient's condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse drug reactions (ADRs) | From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | Toykyo | 151-8589 | Japan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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