UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053652 |
|---|---|
| Receipt number | R000061233 |
| Scientific Title | The Efficacy of Curcumin Patch in Treating Acute Orofacial Pain on Post Labioplasty and Palatoplasty Pediatric Patients |
| Date of disclosure of the study information | 2024/02/19 |
| Last modified on | 2024/02/19 23:08:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
EFEKTIVITAS PATCH KURKUMIN DALAM MENGATASI NYERI OROFASIAL AKUT PASCA TINDAKAN OPERASI CELAH BIBIR DAN ATAU CELAH LANGIT-LANGIT (In Bahasa Indonesia), translated to The efficacy of curcumin patch for managing acute orofacial pain after post-cleft lip and cleft-palate surgery.
Acronym
The COMPRISE Study
Scientific Title
The Efficacy of Curcumin Patch in Treating Acute Orofacial Pain on Post Labioplasty and Palatoplasty Pediatric Patients
Scientific Title:Acronym
The COMPARE PAIN Study
Region
| Asia(except Japan) |
Condition
Condition
The trial was performed on post-cleft lip and cleft palate paediatric patients.
Classification by specialty
| Surgery in general | Pediatrics | Oral surgery |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of curcumin patch in managing post-surgery acute orofacial pain on paediatric patients who underwent cleft-lip and cleft-palate surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of the Face, Leg, Activity, Cry, and Consolability (FLACC) scale as pain indicator. The FLACC scores were measured twice. The basic measurement was immediately after the anaesthesia effect worn off, and the second one is eight hours after the first measurement.
Key secondary outcomes
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
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control 1: the group did not receive any intervention. Pain scoring was measured twice. The first one was immediately after the anaesthesia effect worn off. And the second one is eight hours after the first measurement.
Interventions/Control_2
Intervention 1: the group receive curcumin patch. Curcumin was worn for eight hours. Pain scoring was measured twice. The first one was immediately after the anaesthesia effect worn off. And the second one is eight hours after the first measurement. Once the second measurement was performed, the patch was removed from the patient.
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
| 3 | months-old | <= |
Age-upper limit
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria:
1) had completed the cleft lip and/or cleft palate surgery procedure;
2) aged 36-month-old or less;
3) had no allergic history to curcumin;
4) has an initial pain score of 3 or greater than 3 on a scale of 0-10;
5) did not have any injuries at other parts of the body that have the potential to cause pain, aside from the postoperative wounds.
Key exclusion criteria
Exclusion criteria:
1) consumed additional pain or anti-inflammatory medication in addition to the curcumin patch or the standard analgesic medication prescribed by the doctor in charge;
2) removed the curcumin patch position from the initial location given by the investigator during the study period
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tantry |
| Middle name | |
| Last name | Maulina |
Organization
Faculty of Dentistry, University of Padjadjaran
Division name
Oral and Maxillofacial Department
Zip code
40132
Address
Jl. Sekeloa Selatan no,. 1
TEL
62222504985
tantry.maulina@unpad.ac.id
Public contact
Name of contact person
| 1st name | Tantry |
| Middle name | |
| Last name | Maulina |
Organization
Faculty of Dentistry, University of Padjadjaran
Division name
Oral and Maxillofacial Surgery Department.
Zip code
40132
Address
Jl. Sekeloa Selatan no. 1
TEL
62222504985
Homepage URL
tantry.maulina@unpad.ac.id
Sponsor or person
Institute
Faculty of Dentistry, University of Padjadjaran.
Institute
Department
Personal name
Funding Source
Organization
The Department of Higher Education, Research and Technology of Indonesia
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komite Etik Penelitian/ Research Ethic Committee University of Padjadjaran
Address
Jl. Prof. Eyckman no. 38, Bandung, Indonesia.
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10329533/
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10329533/
Number of participants that the trial has enrolled
55
Results
55
Results date posted
| 2024 | Year | 02 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Baseline characteristics: Post cleft-lip and cleft-palate surgery participants of which the anaesthesia effect has worn off.
Participant flow
Once the participants completed the operation and received the standard post-surgery analgesic agent, initial pain evaluation by the #1 and #2 field researchers was performed. Participants were then randomly assigned to the control group, where the participants did not receive a curcumin patch; or the treatment group, in which the participants received a 100 mg curcumin patch. The #3 field researcher that was assigned for curcumin placement, took a sealed envelope that contained the name of the group the participant was assigned to. Once revealed, this #3 field researcher made a note about which group the patient was assigned to and performed the patch placement procedure. Therefore, the field researchers who were assigned to perform the pain evaluation did not have the knowledge of which group the participant was assigned to.
Adverse events
None
Outcome measures
FLACC scores were collected for two evaluation points.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2022 | Year | 09 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 19 | Day |
Last modified on
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061233
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
