CompletedPhase 2ketamine

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

NCT ID

NCT01653327

Target Enrollment

11 participants

Start Date

2010-06

Est. Completion

2016-08-16

About This Study

* 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.

Conditions Studied

MucositisHead and Neck Cancer

Interventions

•Ketamine
•Placebo

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States