Comparison of Two Sedation Techniques for External Beam Radiotherapy (EBRT) in Paediatric Patients

This is a prospective, interventional, single-centric, randomised, open-label, cross-over study to be conducted in the Radiotherapy suite of Rajiv Gandhi Cancer Institute and Research Centre aiming to compare two sedative techniques, propofol-midazolam and ketamine-midazolam, for external beam radiotherapy in paediatric patients. We shall enroll 16 paediatric patients for 20 radiotherapy sittings each, on 20 consecutive days so that we obtain 320 radiotherapy sittings. All paediatric patients of either sex, aged 6 months to 6 years undergoing external beam radiotherapy shall be included in the study. Exclusion criteria include no parental consent, raised intracranial pressure, radiation simulation, retinoblastoma and allergy to propofol or ketamine. There shall be two arms of the study, the ketamine arm and the propofol arm with 160 radiotherapy sittings in each arm. This shall be a crossover study with the patient randomly being allocated one arm and then crossing over to the other arm after the first 10 radiotherapy sittings. The primary outcome measure would be the Paediatric Sedation State Scale Score measured at pre-procedure, 3 minutes, 6 minutes, 9 minutes after initiation of intervention, at the end of the procedure and at 10minutes and 30 minutes post-procedure. The secondary outcome measures would be heart rate, arterial oxygen saturation, Face Legs Arm Cry Consolibility Scale, Bispectral Index, respiratory rate measured at pre-procedure, 3 minutes, 6 minutes, 9 minutes after initiation of intervention, at the end of the procedure and at 10 minutes and 30 minutes post-procedure, and Richmond Agitation Sedation Scale measured at the end of the procedure and at 10 minutes and 30 minutes post-procedure.