CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 111 enrolled
Drug / intervention
Dexmedetomidine Hydrochloridedrug
Likely dose
Dexmedetomidine Hydrochloride 0.2 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04040439
NCT04040439N/ACompleted

Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)

Pfizer·observational·Posted Jul 31, 2019·Updated Feb 16, 2024

In Brief

An observational study evaluating Dexmedetomidine Hydrochloride for Sedation. Completed, enrolled 111 participants across 1 site.

Detailed Summary

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesJapan

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartJul 30, 2019
Primary CompletionAug 8, 2022
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.9 years ago

Interventions

Dexmedetomidine Hydrochloridedrug

\[Sedation during and after mechanical ventilation in the intensive care setting\] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate.