UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061652 |
|---|---|
| Receipt number | R000070540 |
| Scientific Title | Comparative evaluation of two different drugs administered using the transdermal drug delivery route versus two oral tablets in the management of postendodontic pain: A randomized controlled clinical trial |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/22 04:32:41 |
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Basic information
Public title
Pain Relief Patch Versus Oral Tablet After Root Canal Treatment
Acronym
PATCH-PAIN
Scientific Title
Comparative evaluation of two different drugs administered using the transdermal drug delivery route versus two oral tablets in the management of postendodontic pain: A randomized controlled clinical trial
Scientific Title:Acronym
TREAT-PAIN
Region
| Asia(except Japan) |
Condition
Condition
Post-Endodontic Pain
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate and compare the analgesic efficacy of transdermal and oral drug delivery systems in the management of post-endodontic pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of post-endodontic pain intensity using the Visual Analog Scale (VAS) at different time intervals following root canal treatment.
Key secondary outcomes
Assessment of adverse effects, need for rescue medication, and patient acceptance of transdermal and oral analgesic therapies following endodontic treatment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medicine: Ketoprofen transdermal patch
A ketoprofen 30 mg transdermal patch was applied once to intact skin immediately after endodontic treatment in adult patients. The patch was replaced after 24 hours, with a total of two patches used over 48 hours to provide continuous non-steroidal anti-inflammatory analgesia through sustained transdermal drug delivery. Each patch was applied once daily without overlap. Patients were monitored for postoperative pain relief and local skin reactions during the 48-hour follow-up period.
Interventions/Control_2
Medicine: Fentanyl transdermal patch
A fentanyl 50-mcg transdermal patch is applied to intact skin immediately after endodontic treatment. The patch was applied once and maintained in place for 48 hours to provide continuous opioid analgesia through controlled systemic transdermal drug delivery. No patch replacement or re-dosing was performed during the study period. Patients were monitored over
48 hours for postoperative pain relief and potential adverse effects such as nausea, dizziness, sedation, or local skin reactions.
Interventions/Control_3
Medicine: Diclofenac sodium tablet
A diclofenac sodium 50 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment in adult patients. The drug was given at standard therapeutic dosages for postoperative analgesia. No additional analgesics were routinely provided unless rescue medication was required. Patients were monitored during the 48-hour period for pain relief and potential adverse effects such as gastric discomfort, nausea, or dizziness.
Interventions/Control_4
Medicine: Ibuprofen Tablet
An ibuprofen 400 mg tablet was administered orally every 8 hours for 48 hours following endodontic treatment for postoperative pain management. The drug was given at standard therapeutic dosages as an analgesic and anti-inflammatory agent. No routine additional analgesics were provided unless rescue medication was required. Patients were monitored over the 48-hour period for pain relief and potential adverse effects such as gastric irritation, nausea, or dizziness.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 18 to 60 years
2.Patients diagnosed with symptomatic irreversible pulpitis or symptomatic apical periodontitis
Multi-rooted teeth indicated for single-visit root canal treatment
3. Patients experiencing moderate to severe preoperative pain
4. Systemically healthy individuals
5. Patients willing to participate and comply with follow-up protocol
Key exclusion criteria
1. Patients with a known history of hypersensitivity or adverse reactions to diclofenac, ketoprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), including reactions such as bronchospasm, shock, or urticaria, were excluded from the study.
2. Individuals with a history of active gastric or duodenal ulceration within the previous six months were not included.
3. Patients who were currently receiving NSAIDs or corticosteroid therapy during the study period were excluded.
4. Participants with a medical history of systemic conditions such as bronchial asthma, epilepsy, inflammatory bowel disease, severe hepatic or renal impairment, dengue fever, or any psychological or psychiatric disorders were not considered eligible for inclusion.
5. Pregnant and lactating women were excluded from the study.
6. Patients with a history of antibiotic use during the study period were also excluded.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | CHITRA |
| Middle name | |
| Last name | KUMARI |
Organization
NIMS DENTAL COLLEGE & HOSPITAL, NIMS UNIVERSITY, RAJASTHAN, JAIPUR
Division name
Conservative Dentistry & Endodontics
Zip code
303121
Address
NIMS University Rajasthan, Dr. B.S. Tomar City, Jaipur Delhi Highway, Jaipur ,303121, Rajasthan, INDIA
TEL
+919304336032
chitramallick100@gmail.com
Public contact
Name of contact person
| 1st name | CHITRA |
| Middle name | |
| Last name | KUMARI |
Organization
NIMS DENTAL COLLEGE & HOSPITAL, NIMS UNIVERSITY, RAJASTHAN, JAIPUR
Division name
Conservative Dentistry & Endodontics
Zip code
303121
Address
NIMS University Rajasthan, Dr. B.S. Tomar City, Jaipur Delhi Highway, Jaipur, 303121, Rajasthan, IN
TEL
+919304336032
Homepage URL
chitramallick100@gmail.com
Sponsor or person
Institute
NIMS University, Jaipur, Rajasthan, India
Institute
Department
Personal name
Funding Source
Organization
NIMS University Rajasthan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur
Address
NIMS University Rajasthan, Dr. B.S. Tomar City, Jaipur Delhi Highway, Jaipur ,303121, Rajasthan, INDIA
Tel
18001201020
phd@nimsuniversity.org
Secondary IDs
Secondary IDs
YES
Study ID_1
IEC/P-541/2024
Org. issuing International ID_1
Institutional Ethics Committee, NIMS University Rajasthan, Jaipur
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
NIMS Dental College & Hospital (Jaipur), NIMS University Rajasthan, India
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 22 | 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
80
Results
VAS scores indicated better analgesic efficacy with fentanyl compared to ketoprofen and other comparator groups, showing greater reduction in postoperative pain. Ketoprofen also demonstrated effective pain control, though to a lesser extent than fentanyl. However, fentanyl use was associated with a higher incidence of adverse effects, whereas ketoprofen showed a comparatively better safety profile with fewer adverse events.
Results date posted
| 2026 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study groups were comparable at baseline with no statistically significant differences in age, gender distribution, or baseline VAS scores. The mean age of participants was similar across groups, and baseline pain scores were equivalent prior to intervention.
Participant flow
Eligible participants were enrolled and randomly allocated into four groups: ketoprofen patch, fentanyl patch, oral ibuprofen, and oral diclofenac. Each group received the assigned intervention according to study protocol. Participants were followed up for outcome assessment, and all enrolled participants were included in the final analysis.
Adverse events
Oral NSAIDs were associated with gastrointestinal adverse effects such as gastric discomfort, while transdermal patches were associated with local skin irritation and nausea. Adverse events were more frequent in the fentanyl patch group. All events were mild, and no serious adverse events occurred.
Outcome measures
The primary outcome was postoperative pain intensity measured using the Visual Analog Scale (VAS) at specific postoperative time points. Secondary outcomes included comparison of analgesic efficacy among ketoprofen patch, fentanyl patch, oral ibuprofen, and oral diclofenac, as well as the incidence and nature of adverse events.
Plan to share IPD
No
IPD sharing Plan description
No individual participant data will be publicly shared. De-identified data may be available from the investigator upon reasonable request and ethical approval.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 18 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 18 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 18 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 18 | Day |
Other
Other related information
This study compared the analgesic efficacy and safety of ketoprofen patch, fentanyl patch, oral ibuprofen, and oral diclofenac in the management of postoperative pain. Pain intensity was assessed using the Visual Analog Scale (VAS), and adverse events were recorded. The study findings were partially presented at the IACDE 2025 conference, Chandigarh.
Management information
Registered date
| 2026 | Year | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070540
