Trial Outcomes & Findings for Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash (NCT NCT01566448)

Results Overview

Change in pain score as reported at baseline and after the use of ketamine mouthwash on a numeric scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

1 hour after baseline

Results posted on

2022-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 hour after baseline

Change in pain score as reported at baseline and after the use of ketamine mouthwash on a numeric scale from 0 to 10, with 0 representing no pain and 10 representing the worst pain.

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Change in Pain Scores	2 score on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: 1 day after start of ketamine mouthwashes

Patients will be questioned about time until maximal pain relief and given options of: no effect, 1-15 minutes, 15-30 minutes, 30-45 minutes, 45-60 minutes and greater than 1 hour.

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Time From Dose Administration to Change in Pain Intensity as Reported by Subject. No effect	2 Participants
Time From Dose Administration to Change in Pain Intensity as Reported by Subject. 0-15 minutes	28 Participants

SECONDARY outcome

Timeframe: Day 1 after start of ketamine mouthwashes

Patients will be question about the duration of pain relief and given the option of no effect, less than one hour, 1-2 hours, 2-3 hours, 3-4 hours, greater than 4 hours or N/A.

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Duration of Effect of Pain Reduction <1 hour	14 Participants
Duration of Effect of Pain Reduction 1-2 hours	7 Participants
Duration of Effect of Pain Reduction 2-3 hours	6 Participants
Duration of Effect of Pain Reduction 3-4 hours	0 Participants
Duration of Effect of Pain Reduction >4 hours	1 Participants
Duration of Effect of Pain Reduction No effect	2 Participants

SECONDARY outcome

Timeframe: Days 1 after start of ketamine mouthwashes

Change in IV morphine equivalents of opioid requirements

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Change in Use of Narcotic Analgesics	12 IV morphine equivalents Interval 0.0 to 202.0

SECONDARY outcome

Timeframe: Days 1 after start of ketamine mouthwashes

Change of topical lidocaine uses in 24 hour period

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Change in Topical Lidocaine Usage	1 lidocaine doses per day Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Day 1 after start of ketamine mouthwashes

Sleep quality, as reported by the subject on a numeric scale (1-10) will be used as a surrogate marker of quality of life with 0 indicating no sleep and 10 indicating the best sleep you have had.

Outcome measures

Outcome measures
Measure	Ketamine n=30 Participants Ketamine oral mouthwash 20mg/5ml swish and spit four times daily Ketamine: 20mg/5ml swish and spit four times daily
Change in Sleep Quality	1 score on a scale Interval 1.0 to 10.0

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron Cumpston

West Virginia University Hospitals

Phone: 304-598-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place