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

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 Overview

• Status: Completed
• Conditions: Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Drug: Tantum Verde® mouthwash; Other: Placebo mouthwash

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Naharia, Israel, 2210001
    • Galillee medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tantum Verde® mouthwash; solution of Tantum Verde	Drug: Tantum Verde® mouthwash
Placebo Comparator: placebo mouthwash; saline with mint flavor	Other: Placebo mouthwash; Mouthwash with placebo solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain: reduction in severity based on VAS score.	postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain: time to complete resolution based on VAS score.	postoperative pain using VAS(Visual Analogue Scale) on day 14
Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively	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	bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.
Bleeding: postoperative measures to reduce bleeding	bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.

Secondary Outcome Measures

Outcome Measure	Time Frame
Readmission for any reason.	14 Days after surgery
Duration of hospital stay	day14
Time to return to normal diet and activities.	day 14

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: July 13, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: October 1, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Patients undergoing tonsillectomy with or without adenoidectomy
• Other Study ID Numbers: 0028-14-NHR