Precedex Special Investigation (in Pediatric Patients)

NCT04040439 | Completed Results

• 1 other identifier: C0801023
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sedation

Keywords

Precedex;; Dexmedetomidine Hydrochloride;; Sedation;; intensive care;; pediatric

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Drug Reactions

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Precedex in a participant who received Precedex. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Precedex was assessed by the physician.

  From the start of administration of Precedex (hour 0) to the discharge from the intensive care unit (ICU) (up to Month 33, at the longest).

Secondary Outcomes (1)

• Percentage of Participants Who Were Evaluated as Effective (Responders) by the Physician

  At the end of administration of Precedex (up to Month 33, at the longest)

Study Arms (1)

Dexmedetomidine Hydrochloride

Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation during and after mechanical ventilation in the intensive care setting"

Drug: Dexmedetomidine Hydrochloride

Interventions

Dexmedetomidine Hydrochloride DRUG

\[Sedation during and after mechanical ventilation in the intensive care setting\] 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.

Also known as: Precedex

Dexmedetomidine Hydrochloride

Eligibility Criteria

• Age: 45 Weeks - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting"

You may qualify if:

• Pediatric patients (45 weeks corrected gestational age to \<18 years old) administered this drug for "sedation during and after mechanical ventilation in the intensive care setting.

Sponsors & Collaborators

• Pfizer: lead
• Maruishi Pharmaceutical: collaborator

Study Sites (1)

Pfizer Japan Local Country Office

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: July 30, 2019
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)