The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Western Galilee Hospital-Nahariya

Status: Completed

Conditions: Adenoidectomy; Tonsillectomy

Treatments: Drug: Tantum Verde® mouthwash; Other: Placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02190162

0028-14-NHR

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing tonsillectomy with or without adenoidectomy
• Over 12 years of age
• Signed informed consent by patient or caregiver

Exclusion criteria

• Inability to gargle and spit
• Allergy to one of the solution ingredients
• Significant comorbidity (e.g. diabetes, bleeding disorders)
• Unable/ unwilling to comply with the protocol requirements
• Pregnancy or breast feeding
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study

Withdrawal Criteria:

• Patients did not comply with the protocol requirements

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Tantum Verde® mouthwash

Active Comparator group

Description:

solution of Tantum Verde

Treatment:

Drug: Tantum Verde® mouthwash

placebo mouthwash

Placebo Comparator group

Description:

saline with mint flavor

Treatment:

Other: Placebo mouthwash