The Influence of Tantum Verde® on Recovery Following Tonsillectomy

Tonsillectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190162
• Other study ID #: 0028-14-NHR
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: October 2018
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoidectomy
• Tonsillectomy

Intervention

Drug:
• Tantum Verde® mouthwash

Other:
• Placebo mouthwash
Mouthwash with placebo solution

Locations

Country	Name	City	State
Israel	Galillee medical center	Naharia

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain: reduction in severity based on VAS score.		postoperative pain using VAS(Visual Analogue Scale) on day 14
Primary	Pain: time to complete resolution based on VAS score.		postoperative pain using VAS(Visual Analogue Scale) on day 14
Primary	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
Primary	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.
Primary	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	Readmission for any reason.		14 Days after surgery
Secondary	Duration of hospital stay		day14
Secondary	Time to return to normal diet and activities.		day 14