A Multicenter Randomized Controlled Trial on the Safety and Efficacy of Ketamine Mouthwash for Chemotherapy-Induced Oral Mucositis in Pediatric Patients

Abstract

Background: Oral mucositis (OM) is a common and debilitating adverse effect of chemotherapy in pediatric oncology, resulting in significant pain and impaired nutritional intake. Objectives: This study aimed to evaluate the safety and analgesic efficacy of ketamine mouthwash in children with severe chemotherapy-induced OM. Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving 40 pediatric patients aged 7 - 14 years with World Health Organization (WHO) grade 3 or 4 OM. Participants were randomized to receive either ketamine mouthwash (4 mg/mL) or placebo, administered three times daily for 72 hours. Pain intensity was assessed using a 10-point Numeric Rating Scale (NRS) at baseline and at multiple intervals following intervention. Functional recovery and adverse events were monitored throughout the study. Results: Baseline pain scores were similar between the two groups. Significant reductions in pain were observed in the ketamine group on days two and three (P < 0.0001 and P = 0.0003, respectively). The onset of analgesia occurred within 15 minutes and lasted for 2 - 3 hours. Oral intake improved markedly in the ketamine group, with no adverse events reported. Conclusions: Ketamine mouthwash at a concentration of 4 mg/mL is a safe and effective analgesic for the management of severe OM in pediatric chemotherapy patients. Its rapid onset of action and functional benefits support its use as an adjunctive supportive care measure.