Tantum verde mouthwash for tonsillectomy: A prospective, double-blind, randomized control trial

Objectives: Post-tonsillectomy pain control is still considered a challenge. Topical agents would seem to be an ideal, safe option. Our objective was to compare the efficacy of mouthwash preparation with anti-inflammatory, anesthetic, and analgesic properties (Tantum Verde ^® , 0.15% benzydamine hydrochloride) with that of placebo in improving post-tonsillectomy morbidity. Methods: A prospective, double blind, randomized clinical trial was performed. Patients older than 12-years-of-age who underwent tonsillectomy were recruited. Participants were randomized into 2 groups to receive either 0.15% benzydamine hydrochloride (TV) mouthwash solution (study arm) or a placebo solution. They were instructed to gargle the intervention they received 3 times a day for 7 days following surgery. Primary outcomes were intensity and duration of post-operative pain (using VAS visual analogue score) during a 2-week follow-up period. Secondary outcomes were pain medication demand, readmission, incidence of post-operative bleeding, hospital stay duration, and time to resume normal solid diet. Results: Thirty-nine patients completed the study, of whom 23 received TV and 16 received placebo. The mean age was 23.1 years. There was no significant difference between the groups in the primary or secondary outcomes. Conclusions: The data suggest that topical treatment with TV mouthwash solution was not found to be superior to placebo in the management of post-tonsillectomy pain, bleeding, and return to a regular solid diet. Further research studies should be designed to investigate the ideal treatment for reducing post-tonsillectomy morbidity. Clinical trial registration: NIH identifier: NCT02190762; IRB NHR002814.