Health Condition 1: T451- Poisoning by, adverse effect of and underdosing of antineoplastic and immunosuppressive drugs
Conditions
Interventions
Intervention1: Ketamine Mouthwash: Ketamine mouthwash (prepared as 4 mg of ketamine in 1 ml solution, prepared by diluting marketed iv formulation of ketamine in appropriate pharmaceutical diluent) in
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of 8-18 years of age 2. Received at least 1 dose of cancer chemotherapy 3. Have severe oral mucositis (grade 3 or grade 4 according to WHO Oral Mucositis Grading scale) 4. Have an oral mucositis pain score of 2 or more on Wong Baker faces pain rating scale (0-5)
Exclusion criteria
Exclusion criteria: 1. Have taken a systemic analgesic (such as paracetamol or tramadol) within last 4 hours, or applied topical local anaesthetic (such as lignocaine or xylocaine) to the oral cavity within last 1-hour, of the time of randomisation of the patient in the study groups 2. Received prior ketamine dose within 48 hours of enrolment (by any route) 3. Any contra-indications to the use of ketamine: i. Any documented hypersensitivity to ketamine ii. Signs and symptoms of raised intra cranial pressure iii. Blood pressure above 95th centile for age and height, at least 2 readings 15 minutes apart
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction of oral mucositis pain (on a numeric 6-point scale) after administration of ketamine mouthwash as compared to placeboTimepoint: At 1 hour after administration of mouthwash (ketamine/ placebo) | — |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic agent required at 1 hour of administration of mouthwash (ketamine/ placebo) with doseTimepoint: At 1 hour after administration of mouthwash (ketamine/ placebo);Occurrence of adverse effects of topical ketamine (Sedation, nausea, vomiting, hallucinations, excessive salivation, vertigo, ataxia, any other)Timepoint: Till 4 hours after administration of mouthwash (ketamine/ placebo);Time duration for which the pain reduction effect, if any, lastedTimepoint: Till 4 hours after administration of mouthwash (ketamine/ placebo);Time of onset of oral mucositis pain reduction, if any.Timepoint: Till 4 hours after administration of mouthwash (ketamine/ placebo) | — |
Countries
India
Contacts
Public ContactSatya Prakash
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed