Health Condition 1: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
Conditions
Interventions
Intervention1: 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
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in the pain scores between the two arms as reported on the Numerical rating scale(NRS).Timepoint: At Day 3. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean difference in the pain scores between the two arms at 30 mins and 1 hour as reported on the NRS.Timepoint: At 30 minutes and 1 hour;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.Timepoint: Day 3;Requirement of opioid analgesics expressed as oral morphine equivalents.Timepoint: Day 3;Time to requirement of first systemic opioid analgesic in hours.Timepoint: Day 3;To assess for the change in the grade of the oral mucositis as assessed by the WHO or CTCAE scale.Timepoint: Day 3;To check the lowest pain score achieved during the course of 3 days using the numerical rating scale.Timepoint: Day 3 | — |
Countries
India
Contacts
Public ContactDr. Varun T. M.
Tata Memorial Hospital
Outcome results
None listed