Trial Outcomes & Findings for Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer (NCT NCT01653327)
NCT ID: NCT01653327
Last Updated: 2018-09-28
Results Overview
The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes in pain scores (post-treatment pain score ÷ pre-treatment pain score) will be calculated and similarly analyzed. The proportion of subjects experiencing a reduction in pain scores of \>33% will be calculated.
COMPLETED
PHASE2
11 participants
After 9-10 doses, expected average 1 month
2018-09-28
Participant Flow
Participant recruitment occurred between 5/24/2010-8/3/2016.
Participants were randomized to receive ketamine (K) or placebo (P) in repeating sequences of KPK or PKP. Not all participants completed all sequences. A participant was considered complete if they received at least one dose of K or P and completed the pain assessment.
Participant milestones
| Measure |
All Study Participants
Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline.
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|---|---|
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Overall Study
STARTED
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11
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Overall Study
COMPLETED
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10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Study Participants
Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline.
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|---|---|
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Overall Study
Withdrawal by Subject
|
1
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Baseline Characteristics
Analgesic Effects of Topical Ketamine Mouthwash in Patients Receiving Chemoradiation or Radiotherapy for Head & Neck Cancer
Baseline characteristics by cohort
| Measure |
Cohort
n=10 Participants
All individuals participating in the trial.
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|---|---|
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Age, Continuous
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56.45 Years
n=99 Participants
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Sex: Female, Male
Female
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1 Participants
n=99 Participants
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Sex: Female, Male
Male
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9 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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10 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: After 9-10 doses, expected average 1 monthPopulation: 1-4 pain measurements were obtained per participant. One assessment occurred per administered dose.
The primary analysis is testing and estimating the effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will determine average pain scores. Pain will be measured using a 0-10 scale with 0 representing no pain; 1-3 representing mild pain; 4-6 representing moderate pain; and 7-10 representing severe pain. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval. Proportional changes in pain scores (post-treatment pain score ÷ pre-treatment pain score) will be calculated and similarly analyzed. The proportion of subjects experiencing a reduction in pain scores of \>33% will be calculated.
Outcome measures
| Measure |
Ketamine
n=24 Number of pain assessments
Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
|
Placebo
n=20 Number of pain assessments
The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline.
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|---|---|---|
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Change in Pain Score
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1.167 score on a scale
Standard Deviation 1.37
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1.58 score on a scale
Standard Deviation 1.31
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SECONDARY outcome
Timeframe: After 9-10 doses, expected average 1 monthPopulation: 1-4 measurements of analgesic effects were obtained per participant. One assessment occurred per administered dose.
The secondary analysis is testing and estimating the analgesic effect of ketamine in comparison to placebo. Pain assessment will be analyzed using descriptive statistics. We will also determine average duration of analgesia. The effect of ketamine in comparison to placebo will be estimated with a mean and confidence interval.
Outcome measures
| Measure |
Ketamine
n=13 Total visits where duration was measured
Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
|
Placebo
n=14 Total visits where duration was measured
The placebo consisted of 4 ml of cherry syrup and 1 ml of normal saline.
|
|---|---|---|
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Duration of Analgesic Effect
|
39.231 minutes
Standard Deviation 11.519
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35.357 minutes
Standard Deviation 9.499
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Adverse Events
Ketamine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine
n=9 participants at risk
Ketamine: Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
|
Placebo
n=10 participants at risk
The placebo will consist of 4 ml of cherry syrup and 1 ml of normal saline.
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|---|---|---|
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General disorders
Oral Pain; Grade 1
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33.3%
3/9 • Number of events 3 • Adverse events were collected for the duration of the study, which is up to 6 weeks in total. For reporting purposes, if the adverse event occurred immediately after taking Ketamine or Placebo, the event is associated with that respective group.
|
20.0%
2/10 • Number of events 2 • Adverse events were collected for the duration of the study, which is up to 6 weeks in total. For reporting purposes, if the adverse event occurred immediately after taking Ketamine or Placebo, the event is associated with that respective group.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place