A clinical trial to study the role of ketamine mouthwash for the treatment of severe oral mucositis pain in children with cancer

Phase 2

Conditions: Health Condition 1: T451- Poisoning by, adverse effect of and underdosing of antineoplastic and immunosuppressive drugs

Recruitment & Eligibility

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

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

Primary Outcome Measures

Name	Time	Method
Mean reduction <br/ ><br>of oral mucositis pain (on a <br/ ><br>numeric 6-point scale) <br/ ><br>after administration of ketamine <br/ ><br>mouthwash as compared to <br/ ><br>placeboTimepoint: At 1 hour after <br/ ><br>administration of <br/ ><br>mouthwash (ketamine/ <br/ ><br>placebo)

Secondary Outcome Measures

Name	Time	Method
Analgesic agent <br/ ><br>required at 1 hour <br/ ><br>of administration of <br/ ><br>mouthwash <br/ ><br>(ketamine/ placebo) <br/ ><br>with doseTimepoint: At 1 hour after <br/ ><br>administration of <br/ ><br>mouthwash (ketamine/ <br/ ><br>placebo);Occurrence of <br/ ><br>adverse effects of topical <br/ ><br>ketamine (Sedation, nausea, <br/ ><br>vomiting, <br/ ><br>hallucinations, <br/ ><br>excessive <br/ ><br>salivation, vertigo, <br/ ><br>ataxia, any other)Timepoint: Till 4 hours after <br/ ><br>administration of <br/ ><br>mouthwash (ketamine/ <br/ ><br>placebo);Time duration for <br/ ><br>which the pain <br/ ><br>reduction effect, if <br/ ><br>any, lastedTimepoint: Till 4 hours after <br/ ><br>administration of <br/ ><br>mouthwash (ketamine/ <br/ ><br>placebo);Time of onset of <br/ ><br>oral mucositis pain <br/ ><br>reduction, if any.Timepoint: Till 4 hours after <br/ ><br>administration of <br/ ><br>mouthwash (ketamine/ <br/ ><br>placebo)