UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053305 |
|---|---|
| Receipt number | R000060842 |
| Scientific Title | Efektivitas penggunaan patch kurkumin dalam mengatasi nyeri orofasial akut pasca tindakan operasi celah bibir dan atau celah langit-langit (In Bahasa) |
| Date of disclosure of the study information | 2024/01/10 |
| Last modified on | 2024/01/10 10:08:07 |
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Basic information
Public title
Curcumin Efficacy for Post-operative Acute Pain in Children Study
Acronym
THE CREVICE STUDY
Scientific Title
Efektivitas penggunaan patch kurkumin dalam mengatasi nyeri orofasial akut pasca tindakan operasi celah bibir dan atau celah langit-langit (In Bahasa)
Scientific Title:Acronym
THE CURCUMIN EFFICACY STUDY
Region
| Asia(except Japan) |
Condition
Condition
This trial was conducted on children with cleft lip and palate that went through a corrective operation for the condition. Once the children went through the operation, all patients received standardised post-operative analgesic drugs. Additionally, patients in the intervention group received curcumin patch placed on their chest. Pain evaluation was performed immediately after the anaesthesia effect wore off, and eight hours after the placement of the curcumin patch. Pain evaluation was performed by using pain scale, namely the FLACC scale, and by measuring the Prostaglandin E-2 (PGE2) saliva level.
Classification by specialty
| Medicine in general | Surgery in general | Oral surgery |
| Plastic surgery | Aesthetic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The current study was conducted to compare the efficacy of curcumin patch that contains piperine and curcumin patch that does not contain piperine as an adjuvant analgesic agent for treating acute post-operative pain on children with cleft lip and palate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The decrease of pain level through PGE2 saliva level measurement
Key secondary outcomes
The decrease of pain level through Face, Leg, Activity, Cry and Consolability (FLACC) scale scoring
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The control group. Patients only received standard post-surgery drug.
Interventions/Control_2
First intervention group. Patients received standard post-surgery drug + curcumin patch that contains piperine
Interventions/Control_3
Second intervention group. Patients received standard post-surgery drug + curcumin patch that does not contain curcumin
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
| 3 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
- Aged 36 months old or less;
- Had an initial pain score of (a minimum of) 1 (according to the FLACC pain score);
- Not allergic to curcumin and or piperine and
- Did not have any injuries or inflammation at other areas of the body that might act as another source of pain.
- Willing to participate
Key exclusion criteria
Participants were excluded from the study if:
- participants consumed another analgesic agent aside from the ones prescribed or
- participants removed the patch (those who were assigned to the treatment groups) before eight hours of application,
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tantry |
| Middle name | |
| Last name | Maulina |
Organization
University of Padjadjaran, Bandung, Indonesia
Division name
Oral Surgery Department, Faculty of Dentistry
Zip code
40132
Address
Jl. Sekeloa Selatan no. 1
TEL
62222514985
tantry.maulina@unpad.ac.id
Public contact
Name of contact person
| 1st name | Tantry |
| Middle name | |
| Last name | Maulina |
Organization
University of Padjadjaran, Bandung, Indonesia
Division name
Oral Surgery Department, Faculty of Dentistry
Zip code
40132
Address
Jl. Sekeloa Selatan no. 1
TEL
62222514985
Homepage URL
https://fkg.unpad.ac.id
tantry.maulina@unpad.ac.id
Sponsor or person
Institute
Faculty of Dentistry, University of Padjadjaran
Institute
Department
Personal name
Tantry Maulina
Funding Source
Organization
University of Padjadjaran
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Indonesian
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
The Research Ethics Committee Universitas Padjadjaran, Bandung, Indonesia
Address
Jl. Prof. Eyckman no.38 Bandung
Tel
62222038697
kep@unpad.ac.id
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
Unpad Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0020653923003027
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0020653923003027
Number of participants that the trial has enrolled
75
Results
75
Results date posted
| 2024 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 09 | Month | 24 | Day |
Baseline Characteristics
All participants received suppository Ketoprofen as the main standardised post-surgery analgesic agent (participants who weighed less than 10kg received 50mg of suppository Ketoprofen and those who weighed 10 kg or more received 100 mg of suppository Ketoprofen). The first dose of Ketoprofen was administered upon completion of surgery (immediately after the anesthesia effect wore off, right before participants were sent to their room for post-operative observation), and the second one was 12 hours after the first administration.
Participant flow
All participants were randomly assigned to one of the three groups. Finally included participants were included from the very beginning based on the inclusion criteria. No participant was excluded from the study.
Adverse events
None.
Outcome measures
- Pain intensity based on FLACC score
- Pain intensity based on PGE2 saliva level
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 23 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 23 | Day |
Date trial data considered complete
| 2023 | Year | 01 | Month | 23 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060842
