SedationNCT06085573
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
An observational study of Sedation, run by Pfizer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Sedation
- What is being tested?
- Dexmedetomidine Hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 111 participants
- Where
- 1 siteJapan
- Study dates
- 18 Oct 2023to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
Who may be able to join
- Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
Who cannot join
- No exclusion criteria is set out in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precedex Intravenous Solution Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)
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.
- Conditions
- Sedation
- Being tested
- Dexmedetomidine Hydrochloride
- Keywords
- Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, non-intubated;, pediatric;, non-invasive procedures and tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called Precedex
<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.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse drug reactions (ADRs)
Measured: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start18 Oct 2023
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085573
- Sponsor's protocol ID
- C0801044
- Other IDs
- NCT06085573
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precedex Intravenous Solution Special Investigation (Sedation of Non-intubated Pediatric Patients for Non-invasive Procedures and Tests)
- ClinicalTrials.gov ID
- NCT06085573
- Acronym / sponsor ID
- C0801044
- Conditions
- Sedation
- Keywords
- Precedex;, Dexmedetomidine Hydrochloride;, Sedation;, non-intubated;, pediatric;, non-invasive procedures and tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Hydrochloride | – | Drug: Dexmedetomidine HydrochloridePediatric patients (1 month to < 18 years old) administered Precedex (Dexmedetomidine Hydrochloride) for "sedation of non-intubated pediatric patients for non-invasive procedures and tests" |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
Key inclusion criteria (1 listed)
- Pediatric patients (1 month to < 18 years old) administered Precedex for "sedation of non-intubated pediatric patients for non-invasive procedures and tests"
Key exclusion criteria (1 listed)
- No exclusion criteria is set out in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: Precedex<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. | Drug | Dexmedetomidine Hydrochloride |
Primary outcome
Number of participants with adverse drug reactions (ADRs)
Time frame: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Related trials for Sedation
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingPhase 3
Optimizing Pain Treatment in Children On Mechanical Ventilation
Mechanical Ventilation, Pediatric Acute Respiratory Failure
Recruiting
Recovery Time With the Application of ALDRETE Score in Patients Undergoing Gastrointestinal Endoscopy
Patients Undergoing Gastrointestinal Endoscopy
Recruiting
A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation
Atrial Fibrillation (AF)
Active, not recruiting
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
Atrial Fibrillation (Paroxysmal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedation, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse drug reactions (ADRs) (time frame: From the time of patient assessment before the start of administration of Precedex to 1 hour after the completion or discontinuation of administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.