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Completed

NCT Number: NCT02190162

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.

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Key information

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galillee medical center

Nahariya, 2210001, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tantum Verde® mouthwash

Drug

Placebo Mouthwash

Other

Mouthwash with placebo solution

Primary outcomes

  1. Pain: reduction in severity based on VAS score.

    Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14

  2. Pain: time to complete resolution based on VAS score.

    Time frame: postoperative pain using VAS(Visual Analogue Scale) on day 14

  3. Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively

    Time frame: Data of Pain medication: postoperative pain medication type, dosage and reduction in the demand postoperatively will be collected on day 14

  4. Bleeding: time to complete cessation, need for re-operation

    Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.

  5. Bleeding: postoperative measures to reduce bleeding

    Time frame: bleeding score will be Measured according to:bleeding, no bleeding and surgery required for 14 days after surgery.

Secondary outcomes

  1. Readmission for any reason.

    Time frame: 14 Days after surgery

  2. Duration of hospital stay

    Time frame: day14

  3. Time to return to normal diet and activities.

    Time frame: day 14

Sponsors and collaborators

Lead sponsor

Western Galilee Hospital-Nahariya

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 15, 2014
Registry last updated
Oct 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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