NCT02190162

The Influence of Tantum Verde® on Recovery Following Tonsillectomy

A Prospective Double-blined Randomized Trial to Evaluate The Influence of Tantum Verde® on Recovery Following Tonsillectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects of Tantum Verde® for improving recovery following tonsillectomy Study design: A prospective double-blined randomized trial. Sample size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be treated with a placebo. The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign the inform consent in one of two places: in the departments before the surgery or in the clinic in the visit before the surgery. The patients will be evaluated for their ability to gargle and spit water before the surgery, after which they will be assigned to either the treatment group who will get a solution of Tantum Verde or the control group who will receive saline with mint flavor, both in identicle bottles. Randomization will be done using a random number generator program. The patients will be asked to gargle and spit the solution they received three times a day for 30 seconds, for the following week after surgery.

Conditions

• Tonsillectomy
• Adenoidectomy

Interventions

Type	Name	Description
DRUG	Tantum Verde® mouthwash
OTHER	Placebo mouthwash	Mouthwash with placebo solution

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-07-15
• Last updated: 2018-10-02

Locations

1 site across 1 country: Israel