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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
60
Mouthwash with placebo solution
Galillee medical center
Nahariya, Israel
Pain: reduction in severity based on VAS score.
Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain: time to complete resolution based on VAS score.
Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively
Time frame: Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14
Bleeding: time to complete cessation, need for re-operation
Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Bleeding: postoperative measures to reduce bleeding
Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Readmission for any reason.
Time frame: 14 Days after surgery
Duration of hospital stay
Time frame: day14
Time to return to normal diet and activities.
Time frame: day 14
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