A Study to Learn About the Study Medicine - Precedex in Children From Japan.
NCT ID: NCT06085573
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
111 participants
OBSERVATIONAL
2023-10-18
2025-06-20
Brief Summary
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This study is seeking for children who are 1 month to less than 18 years old.
The patients are planned to be looked over:
* From the time of patient check before receiving Precedex
* To 1 hour after the completion or stop of using Precedex.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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"
Dexmedetomidine Hydrochloride
\<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.
Interventions
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Dexmedetomidine Hydrochloride
\<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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1 Month
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
Toykyo, , Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06085573
Identifier Type: REGISTRY
Identifier Source: secondary_id
C0801044
Identifier Type: -
Identifier Source: org_study_id
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