| CTRI Number |
CTRI/2024/06/069061 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Process of Care Changes
Other (Specify) [cancer pain] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
compare the effect of Ketoprofen and Lignocaine skin patches for pain relief in cancer patients |
|
Scientific Title of Study
|
Comparative evaluation of ketoprofen and 5 percentlignocaine transdermal patch as adjuvant to morphine and other pain medications for acute localized area cancer painmanagement |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Laltanpuii Sailo |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room No 104
First floor
Department of Anaesthesiology and Critical Care,Neigrihms
Mawdiangdiang 793018,Shillong,Meghalaya
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9436154838 |
| Fax |
2538033 |
| Email |
wendysailo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laltanpuii Sailo |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room No 104
First floor
Department of Anaesthesiology and Critical Care,Neigrihms
Mawdiangdiang 793018,Shillong,Meghalaya
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9436154838 |
| Fax |
2538033 |
| Email |
wendysailo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laltanpuii Sailo |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room No 104
First floor
Department of Anaesthesiology and Critical Care,Neigrihms
Mawdiangdiang 793018,Shillong,Meghalaya
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
9436154838 |
| Fax |
2538033 |
| Email |
wendysailo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute(NEIGRIHMS)
Department of anaesthesiology and intensive care
opd building ,
first floor
Room no:104
mawdiangdiang
shillong
meghalaya 793018
India
|
|
|
Primary Sponsor
|
| Name |
Norh Eastern Institute of Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
NEIGRIHMS ,MAWDIANGDIANG ,SHILLONG MEGHALAYA-793018 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| laltanpuii sailo |
North eastern indira Gandhi regional institute of health and medical sciences |
Room No 104
First floor,OPD Building
Department of Anaesthesiology and Critical care ,Neigrihms ,Mawdiangdiang,Shillong meghalaya
East Khasi Hills
MEGHALAYA |
9436154838
2538033
wendysailo@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee ,North Eastern Indira Gandhi Regional Institute of health and medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C800||Disseminated malignant neoplasm, unspecified, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C729||Malignant neoplasm of central nervous system, unspecified, (4) ICD-10 Condition: C759||Malignant neoplasm of endocrine gland, unspecified, (5) ICD-10 Condition: C411||Malignant neoplasm of mandible, (6) ICD-10 Condition: C63||Malignant neoplasm of other and unspecified male genital organs, (7) ICD-10 Condition: C577||Malignant neoplasm of other specified female genital organs, (8) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (9) ICD-10 Condition: C169||Malignant neoplasm of stomach, unspecified, (10) ICD-10 Condition: C390||Malignant neoplasm of upper respiratory tract, part unspecified, (11) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ketoprofen patch 30 mg |
application of transdermal ketoprofen patch for pain relief in localized cancer patients
Patch will be applied twice,each patch for 24 hours over the area of pain. |
| Intervention |
lignocaine patch 5% |
application of transdermal lignocaine patch for pain relief in localized cancer patients
Patch will be applied twice,each patch for 24 hours over the area of pain. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult cancer patients who need localized acute localized pain area medication in addition to morphine and other pain medicines.
Patients with NRS score of more than 4 .
|
|
| ExclusionCriteria |
| Details |
Patients with known allergy to Local Anaesthetic or NSAID |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain score
NRS (0 TO 10) AND VAS(0 TO 100) |
Post application pain is assessed in
3 HOURS,6 HOURS ,12 HOURS AND 24HOURS,36 HOURS AND 48 HOURS over telephone |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effect on the quality of life
|
after 48 hours ,then weekly for 1 month |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cancer causes pain that may be localized due to local spread ,metastasis or other causes. Controlling pain is of utmost importance for a better end of life care. cancer pain may not be adequately relieved by opioids alone and other systemic analgesics.So we would like to use transdermal patches for control acute pain in these patients. Trandermal patches are less invasive and has less side effects and they reduce opioid requirements. |