The Influence of Tantum Verde® on Recovery Following Tonsillectomy

NCT02190162 | Completed DMC

• 1 other identifier: 0028-14-NHR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Adenoidectomy

Keywords

Patients undergoing tonsillectomy with or without adenoidectomy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Readmission for any reason.

  14 Days after surgery

• Duration of hospital stay

  day14

• Time to return to normal diet and activities.

  day 14

Study Arms (2)

Tantum Verde® mouthwash

ACTIVE COMPARATOR

solution of Tantum Verde

Drug: Tantum Verde® mouthwash

placebo mouthwash

PLACEBO COMPARATOR

saline with mint flavor

Other: Placebo mouthwash

Interventions

Tantum Verde® mouthwash DRUG

Tantum Verde® mouthwash

Placebo mouthwash OTHER

Mouthwash with placebo solution

placebo mouthwash

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galillee medical center

Nahariya, 2210001, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 15, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 2, 2018

Record last verified: 2018-10

Locations

IL (1)