| CTRI Number |
CTRI/2024/01/062050 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
28/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative trial of morphine mouthwash and ketamine mouthwash for oral mucositis |
|
Scientific Title of Study
|
Morphine Mouthwash Versus Ketamine Mouthwash For Acute Pain In Patients Of Hematolymphoid Cancers With Chemotherapy Induced Oral Mucositis - A Randomised Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Jayita Deodhar |
| Designation |
Professor in charge |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 132, Department of Palliative Medicine,
Ground Floor, Main Building,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jayita Deodhar |
| Designation |
Professor in charge |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 132, Department of Palliative Medicine,
Ground Floor, Main Building,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
jukd2000@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Varun T. M. |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Room no 75, Department of Palliative Medicine,
Ground Floor, Main Building,
Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224177000 |
| Fax |
|
| Email |
varuntmv95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Department Of Palliative Medicine, Ground Floor, Main Bldg, Tata Memorial Hospital,
E. Borges marg, Parel ,
Mumbai 400012
|
| 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 |
| Dr Jayita Deodhar |
Tata Memorial Hospital |
Room no 132, Department of Palliative Medicine,
Ground Floor, Main Building,
Tata Memorial Hospital,
Dr E. Borges road,
Parel,
Mumbai 400012
Mumbai
MAHARASHTRA |
022224177000
jukd2000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - II , TMH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ketamine |
Ketamine Mouthwash [Ketamine mouthwash will be prepared by dissolving 50mg of IV ketamine in 15 ml of 5% dextrose. 18 syringes each containing 15ml of this ketamine mouthwash will be dispensed to the patients]. Patients will use this for mouthwash 6 times a day for 3 days. |
| Comparator Agent |
Morphine |
Morphine Mouthwash [Morphine mouthwash will be prepared by crushing and dissolving 2g of Oral Morphine sulphate tablet in 1000 ml of 5% dextrose. 18 syringes each containing 15ml of this morphine mouthwash will be dispensed to the patients]. Patients will use this mouthwash for 6 times a day for 3 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
18 years of age or older
Received at least one dose of chemotherapy
Having oral mucositis pain score on NRS more than or equal to 6
Able to do mouthwash without swallowing
Able to sign the informed consent
|
|
| ExclusionCriteria |
| Details |
Any documented previous hypersensitivity to ketamine
Local oral infection
Received prior ketamine or morphine doses by any route within 48 h of study initiation.
Pregnant or breastfeeding.
Patients with hypertension, history of epilepsy and any cardiac conditions.
History of any psychiatric disorder that is at the risk of exacerbation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean difference in the pain scores between the two arms as reported on the Numerical rating scale(NRS). |
At Day 3. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean difference in the pain scores between the two arms at 30 mins and 1 hour as reported on the NRS. |
At 30 minutes and 1 hour |
| To assess for the change in the grade of the oral mucositis as assessed by the WHO or CTCAE scale. |
Day 3 |
| To check the lowest pain score achieved during the course of 3 days using the numerical rating scale. |
Day 3 |
| Numbers and types of adverse effects occurred during the study as reported by the patient using NOSE and also the patient reported adverse effects for ketamine. |
Day 3 |
| Time to requirement of first systemic opioid analgesic in hours. |
Day 3 |
| Requirement of opioid analgesics expressed as oral morphine equivalents. |
Day 3 |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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 Yet Recruiting |
| 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
|
Patients of hematolymphoid cancers who receive intense chemotherapy develop a dreaded and painful condition called oral mucositis which potentiates the need for TPN, opioid analgesics and can also lead to interruption in the treatment and affects the overall quality of life. We hypothesize that Ketamine mouthwash is more beneficial than the morphine mouthwash for treating acute severe pain of chemotherapy induced oral mucositis. The aim of this study is to find out the effectiveness of Ketamine mouthwash versus morphine mouthwash in treating the moderate to severe oral mucositis pain due to chemotherapy. The recruited patients will be randomised to either of the groups using computer generated sequence and will be treated using basic oral care guidelines along with morphine mouthwash in one group and ketamine mouthwash in another group. The pain scores will be recorded at base line and will be recorded daily for 3 days and the scores at day 3 will be compared to baseline pain scores.
|