The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Not Applicable

Completed

• Conditions: Tonsillectomy; Adenoidectomy
• Interventions: Drug: Tantum Verde® mouthwash; Other: Placebo mouthwash

• Registration Number: NCT02190162
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-16
• Study Start: 2014-07
• Study First Submitted QC: 2014-07-13
• Study First Posted: 2014-07-15
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tantum Verde® mouthwash	Tantum Verde® mouthwash	solution of Tantum Verde
placebo mouthwash	Placebo mouthwash	saline with mint flavor

Primary Outcome Measures

Name	Time	Method
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.
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: 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

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

Trial Locations

Locations (1)

Galillee medical center; 🇮🇱 Naharia, Israel