UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057957 |
|---|---|
| Receipt number | R000066236 |
| Scientific Title | Investigation of the pain-relieving effect of nitrous oxide on traumatic trigeminal neuropathic pain: a case series |
| Date of disclosure of the study information | 2025/05/24 |
| Last modified on | 2025/07/15 13:49:02 |
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Basic information
Public title
Investigation of the pain-relieving effect of nitrous oxide on traumatic trigeminal neuropathic pain: a case series
Acronym
Effects of nitrous oxide on traumatic trigeminal neuropathic pain: a case series
Scientific Title
Investigation of the pain-relieving effect of nitrous oxide on traumatic trigeminal neuropathic pain: a case series
Scientific Title:Acronym
Effects of nitrous oxide on traumatic trigeminal neuropathic pain: a case series
Region
| Japan |
Condition
Condition
Trigeminal neuropathic pain
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the analgesic effect of nitrous oxide (N2O) on traumatic trigeminal neuropathic pain.
Basic objectives2
Others
Basic objectives -Others
To investigate the changes in pain intensity on traumatic trigeminal neuropathic pain by N2O.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in pain intensity (numerical rating scale) of traumatic neuropathic pain before and after N2O administration.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients were eligible for inclusion if they met at least one of the following criteria: 1) Inadequate pain control despite optimal treatment with at least two classes of recommended pharmacological agents for neuropathic pain (including anticonvulsants and/or antidepressants), 2) Intolerance to standard pharmacological treatments due to adverse effects, 3) Contraindications to standard pharmacological treatments due to comorbidities, drug interactions, or other clinical factors.
Key exclusion criteria
Patients were excluded if they presented with any contraindications to nitrous oxide administration, and inability to provide informed consent.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-8570
Address
1-23 Ogawacho Yokosuka-shi Kanagawa, Japan
TEL
+81-46-822-8896
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kuroda |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-8570
Address
1-23 Ogawacho Yokosuka-shi Kanagawa, Japan
TEL
+81-46-822-8896
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
the Ethics Committee of Kanagawa Dental University
Address
82 Inaoka-cho Yokosuka-shi, Japan
Tel
+81-46-822-8751
kenkyo@kdu.ac.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
| 2025 | Year | 05 | Month | 24 | 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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | 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
This case series is a retrospective obsavational study.
Management information
Registered date
| 2025 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066236
