Phase 2
Completed N=11
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Source: ClinicalTrials.gov NCT01653327 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Change in Pain Score — 1.167; 1.58 score on a scale — p=0.3198
Summary
* 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score |
1.167; 1.58 | 0.3198 |
| SECONDARY Duration of Analgesic Effect |
39.231; 35.357 | 0.3522 |
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
Data sourced from ClinicalTrials.gov (NCT01653327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.