Comparative evaluation of benzydamine oral rinse in children with antineoplastic-induced stomatitis

This nonblinded, crossover study was undertaken to compare the extent and duration of analgesia after administration of benzydamine 0.15% oral rinse and Hospital for Sick Children (HSC) mouthwash for pain (nystatin 7000 U/ml, lidocaine viscous 0.58 ml/ml in NaCl 0.9%) in pediatric patients with antineoplastic-induced stomatitis. Each mouthwash was administered as a paint or a gargle q2h while the child was awake on two consecutive days. Patients older than three years were asked to describe their pain by means of a pictorial or a visual analog scale. Pain was assessed by the investigator, parent, or nurse caring for the patient as well as the patient whenever possible before each dose and 10, 30, and 60 minutes after the first three doses each day for four days. Stomatitis severity was graded daily. Four patients completed the study protocol; an additional three patients dropped out of the study due to severe stinging when benzydamine oral rinse was administered. The case histories of the patients who completed the study are presented. Both preparations reduced pain for at least one hour in most instances but not for two hours. Three of four patients elected to continue treatment with HSC mouthwash for pain. Study recruitment was halted due to the ethical concern of continuing with the knowledge that benzydamine oral rinse causes oral pain and stinging, especially in patients with severe stomatitis.

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