Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head and Neck Cancer

• The primary objective is to determine the reduction in pain score by ketamine mouthwash compared to placebo in head and neck cancer patients with refractory mucositis.
• The secondary objectives are to describe the duration of analgesia and adverse effects associated with ketamine and placebo.

• Mucositis
• Head and Neck Cancer

• Drug: Ketamine
  Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
• Drug: Placebo

• Active Comparator: Ketamine
  Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
  Intervention: Drug: Ketamine
• Placebo Comparator: Placebo
  The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
  Intervention: Drug: Placebo

Inclusion Criteria:

• Subjects diagnosed with head and neck tumors (any histology) receiving ongoing chemoradiation or radiation therapy
• Subjects with mucositis pain refractory to topical management, defined as any self-reported pain score of > 2 in the 24 hours prior to enrollment despite use of topical agents as prescribed
• Age ≥ 18 years
• Ability to understand and willingness to consent and to sign consent form

Exclusion Criteria:

• Active substance abuse at time of registration (alcohol, drugs, non-prescription use of controlled substances)
• Subjects with history of allergic reactions to ketamine
• Persistent oral bleeding: > 15 mL (estimated) per day
• Pregnancy or breast feeding