PEP Topic 

Tetracaine is a local anesthetic. Tetracaine gel, containing a mixture of tetracaine, miconazole, and ethanol, was used as a mouthwash and evaluated for effectiveness in mucositis pain relief.

Effectiveness Not Established

Research Evidence Summaries

Alterio, D., Jereczek-Fossa, B.A., Zuccotti, G.F., Leon, M.E., Sale, E.O., Pasetti, M., … Orecchia, R. (2006). Tetracaine oral gel in patients treated with radiotherapy for head-and-neck cancer: Final results of a phase II study. International Journal of Radiation Oncology, Biology, Physics, 64, 392–395.

doi: 10.1016/j.ijrobp.2005.07.301

Intervention Characteristics/Basic Study Process:

  • Patients were given a tetracaine gel consisting of tetracaine HCL 1.5%, miconazole 2%, ethanol 5%, glycerin 10%, saccharin 0.6%, water 65.3%, starch 15%, tween 20.5%, and flavor 0.5%.
  • Patients were instructed to apply the gel on oral mucosa after using mouthwash and 30 minutes before and after meals, approximately six times per day. Gel use was continued until resolution of pain.
  • Patients were placed into two groups for statistical analysis: no pain relief (grade 1) or presence of pain relief (grade 2, 3, and 4).

Sample Characteristics:

  • The studied consisted of 50 patients with head and neck cancer.
  • Median age was 61  years with a range of 28–73.
  • Patients were receiving external beam radiation therapy (XRT) and had oral mucositis of grade 2 or more. Twenty-two patients (44%) had grade 2 mucositis, and 28 patients (56%) had grade 3 or more mucositis.


The study was conducted between July 2000 and December 2003.

Study Design:

This was a prospective, descriptive study.

Measurement Instruments/Methods:

  • Patients were given a questionnaire to evaluate the effectiveness of the gel using a 1–4 verbal subjective scale with grade 1 = no pain relief and grade 4 = highest grade of pain relief.
  • The feasibility and toxicity profile of the tetracaine gel in reducing oral pain were evaluated after a week of gel administration.
  • Other indirect parameters included the necessity of drug administration, gastrostomy-tube or parental infusion, weight loss, and interruption of XRT.
  • The radiation oncologist used the Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer (RTOG-EORTC) scale to evaluate results and determined other supportive therapy.


  • A majority of patients (79.2%) reported a reduction in oral cavity pain, and 82.9% reported no side effect. Most patients (71%) had no difficulty in gel application. Some patients reported unpleasant taste (12%) and interference with food taste (39%).
  • Planned XRT was less interrupted, although this was difficult to evaluate because of the lack of a control group.


  • The study did not include a control group.
  • The sample size was small.