Sedation
Conditions
Keywords
Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, non-intubated;, pediatric;, non-invasive procedures and tests
Brief summary
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: * From the time of patient check before receiving Precedex * To 1 hour after the completion or stop of using Precedex.
Interventions
DRUGDexmedetomidine 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.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients (1 month to \< 18 years old) administered Precedex for sedation of non-intubated pediatric patients for non-invasive procedures and tests
Exclusion criteria
* No
Design outcomes
Primary
| Measure | 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 |
Countries
Japan
Outcome results
None listed