2.1 Study design and patients
This study was conducted from October 2018 to February 2020 over 17 months at the Department of Pediatrics and Department of Medical Oncology in All India Institute of Medical Sciences (AIIMS), New Delhi, India. The Institute Ethics Committee approved the study protocol (IECPG-328/18.07.2018, RT-1/2018). The trial was registered in the Clinical Trial Registry of India [Trial registration number CTRI/2018/08/015499].
Patients were eligible for enrolment if they were between 8 to 18 years of age, received at least one cycle of cancer chemotherapy and had severe OM (grade-III or grade-IV by WHO oral mucositis grading scale) with an OM pain score of 2 or more (on a 6-point Wong-Baker faces pain rating scale16, with 0 being no pain and 5 being maximum pain). The exclusion criteria included intake of a systemic analgesic within 4 hours or topical analgesic to the oral cavity within one hour before randomization, administration of ketamine by any route within 48 hours of randomization, and any contra-indications to the use of ketamine (documented hypersensitivity, raised intracranial pressure, hypertension). In all the cases, written informed consent was taken from parent/ legally authorized representative (LAR).