UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051859 |
|---|---|
| Receipt number | R000059076 |
| Scientific Title | Accuracy of predicted plasma concentration of fentanyl in children |
| Date of disclosure of the study information | 2023/08/10 |
| Last modified on | 2024/02/07 12:59:18 |
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Basic information
Public title
Accuracy of predicted plasma concentration of fentanyl in children
Acronym
Accuracy of predicted plasma concentration of fentanyl in children
Scientific Title
Accuracy of predicted plasma concentration of fentanyl in children
Scientific Title:Acronym
Accuracy of predicted plasma concentration of fentanyl in children
Region
| Japan |
Condition
Condition
Pediatric patients 0-15 years of age undergoing general anesthesia
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure blood concentrations of fentanyl in pediatric patients, including neonates, and compare them with predicted concentrations from existing fentanyl pharmacokinetic models to confirm the accuracy of the predictions.
If there is a large discrepancy between the measured values and the predictions by the existing model, we will attempt to correct the existing pharmacokinetic model using the measured values from this study.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Predictive Accuracy of Existing Fentanyl Pharmacokinetic Models.
Key secondary outcomes
Consider whether or not a corrected pharmacokinetic model is required.
If necessary, a corrected pharmacokinetic model will be created.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients from 0 to 15 years old undergoing general anesthesia at Chiba Children's Hospital.
Patients who will have arterial pressure lines secured during surgery.
Patients who will be admitted to the ICU or NICU after surgery.
Patients who can continue to have blood drawn from the arterial pressure line after admission.
Key exclusion criteria
Patients on cardiopulmonary bypass
Patients with liver dysfunction
Patients with renal impairment
Patients with metabolic disorders
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Hara |
Organization
Chiba Children's Hospital
Division name
Department of Anesthesiology
Zip code
2660007
Address
579-1 Heda-cho, Midori-ku, Chiba-shi, Chiba
TEL
0432922111
mhara@room.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Hara |
Organization
Chiba Children's Hospital
Division name
Department of Anesthesiology
Zip code
266-0007
Address
579-1 Heda-cho, Midori-ku, Chiba-shi, Chiba
TEL
0432922111
Homepage URL
mhara@room.ocn.ne.jp
Sponsor or person
Institute
Chiba Children's Hospital
Institute
Department
Personal name
Mariko Hara
Funding Source
Organization
Terumo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba Children's Hospital Ethics Committee
Address
579-1 Heda-cho, Midori-ku, Chiba-shi, Chiba
Tel
0432922111
kodomo_ijikei@mz.pref.chiba.lg.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pediatric patients aged 0 to 15 years who received general anesthesia at Chiba Children's Hospital from August 9, 2023 will be included in the study.
Fentanyl will be administered intraoperatively and the residual fentanyl concentration will be measured postoperatively.
The measured fentanyl concentrations will be compared with predicted concentrations calculated from existing pharmacokinetic models.
Management information
Registered date
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
