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Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash

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ClinicalTrials.gov Identifier: NCT01566448
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Aaron Cumpston, PharmD, BCOP, West Virginia University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mucositis
Intervention Drug: Ketamine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
  93.3%
>=65 years
2
   6.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
17
  56.7%
Male
13
  43.3%
1.Primary Outcome
Title Change in Pain Scores
Hide Description 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.
Time Frame 1 hour after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: score on a scale
2
(0 to 10)
2.Secondary Outcome
Title Time From Dose Administration to Change in Pain Intensity as Reported by Subject.
Hide Description 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.
Time Frame 1 day after start of ketamine mouthwashes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
No effect
2
   6.7%
0-15 minutes
28
  93.3%
3.Secondary Outcome
Title Duration of Effect of Pain Reduction
Hide Description 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.
Time Frame Day 1 after start of ketamine mouthwashes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
<1 hour
14
  46.7%
1-2 hours
7
  23.3%
2-3 hours
6
  20.0%
3-4 hours
0
   0.0%
>4 hours
1
   3.3%
No effect
2
   6.7%
4.Secondary Outcome
Title Change in Use of Narcotic Analgesics
Hide Description Change in IV morphine equivalents of opioid requirements
Time Frame Days 1 after start of ketamine mouthwashes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: IV morphine equivalents
12
(0 to 202)
5.Secondary Outcome
Title Change in Topical Lidocaine Usage
Hide Description Change of topical lidocaine uses in 24 hour period
Time Frame Days 1 after start of ketamine mouthwashes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: lidocaine doses per day
1
(0 to 8)
6.Secondary Outcome
Title Change in Sleep Quality
Hide Description 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.
Time Frame Day 1 after start of ketamine mouthwashes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine
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Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

Overall Number of Participants Analyzed 30
Median (Full Range)
Unit of Measure: score on a scale
1
(1 to 10)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine
Hide Arm/Group Description

Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily

All-Cause Mortality
Ketamine
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Ketamine
Affected / at Risk (%)
Total   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aaron Cumpston
Organization: West Virginia University Hospitals
Phone: 304-598-4000 ext 73350
EMail: cumpstona@wvumedicine.org
Publications:
Ketamine. Clinical Pharmacology Online. Elsevier/Gold Standard, Inc. 15 Nov 2011.
Layout table for additonal information
Responsible Party: Aaron Cumpston, PharmD, BCOP, West Virginia University
ClinicalTrials.gov Identifier: NCT01566448    
Other Study ID Numbers: WVU041011
First Submitted: March 27, 2012
First Posted: March 29, 2012
Results First Submitted: May 29, 2018
Results First Posted: January 11, 2021
Last Update Posted: January 11, 2021