UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060292 |
|---|---|
| Receipt number | R000066444 |
| Scientific Title | Current Evidence on the Use of Opioid Analgesics for Moderate to Severe Pain in Children with Cancer: A Scoping Review |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/08 00:17:47 |
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Basic information
Public title
Current Evidence on the Use of Opioid Analgesics for Moderate to Severe Pain in Children with Cancer: A Scoping Review
Acronym
Current Evidence on the Use of Opioid Analgesics for Moderate to Severe Pain in Children with Cancer: A Scoping Review
Scientific Title
Current Evidence on the Use of Opioid Analgesics for Moderate to Severe Pain in Children with Cancer: A Scoping Review
Scientific Title:Acronym
SCOPE-OPCC Study
Region
| Japan |
Condition
Condition
Pediatric cancer
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the types, effectiveness, and safety profiles of opioids used for moderate to severe pain in pediatric cancer patients through a scoping review of published literature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and Safety of Opioid Analgesics
Improvement in Quality of Life (QOL) with Opioid Analgesics
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Pediatric cancer patients under 18 years of age diagnosed with a malignant tumor.
2. Patients with moderate or severe cancer-related pain.
3. Patients who were administered opioid analgesics.
4. Interventional studies (randomized controlled trials, non-randomized controlled trials, single-arm studies) and observational studies (cross-sectional studies, descriptive studies, cohort studies, case-control studies, case series studies).
5. Papers in English or Japanese.
6. Studies conducted in regions with established healthcare systems.
Key exclusion criteria
1. Studies including adults only
2. Studies focusing on postoperative, traumatic, or non-cancer pain
3. Studies evaluating non-opioid analgesics exclusively
4. Reviews, Guidelines, Letters, Editorials, Commentaries, Conference abstracts.
5. Conference abstracts without accessible full text
6. Case reports (n < 5) will be excluded
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | YOSHIHIRO |
| Middle name | |
| Last name | NAGAI |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
6028566
Address
465, Kjiicho, Kamigyo-ku, Kyoto-Shi, Kyoto, Japan
TEL
81-75-251-5177
ynonc2022@gmail.com
Public contact
Name of contact person
| 1st name | YOSHIHIRO |
| Middle name | |
| Last name | NAGAI |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
602-8566
Address
465, Kjiicho, Kamigyo-ku, Kyoto-Shi, Kyoto, Japan
TEL
81-75-251-5177
Homepage URL
ynonc2022@gmail.com
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable
Address
Not applicable
Tel
Not applicable
Not applicable
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
| 2026 | Year | 01 | Month | 08 | 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
612
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 1977 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a scoping review, and therefore, ethical committee approval is not required. The date of [January 1, 1977] has been entered for convenience as it is a mandatory field in the system.
Management information
Registered date
| 2026 | Year | 01 | Month | 08 | Day |
Last modified on
| 2026 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066444
