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Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain

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ClinicalTrials.gov Identifier: NCT02920528
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : April 15, 2021
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
Air Force Research Laboratory
Information provided by (Responsible Party):
David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Drug: Ketamine
Drug: Placebo
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine
Hide Arm/Group Description

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

Period Title: Overall Study
Started 35 36 35
Completed 32 35 30
Not Completed 3 1 5
Reason Not Completed
Incomplete Data             1             1             1
Adverse Event             0             0             3
Did not meet inclusion criteria             2             0             1
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine Total
Hide Arm/Group Description

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

Total of all reporting groups
Overall Number of Baseline Participants 32 35 30 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 35 participants 30 participants 97 participants
47.6  (15) 44.3  (11.2) 47.8  (11.5) 46.5  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 35 participants 30 participants 97 participants
Female
18
  56.3%
21
  60.0%
18
  60.0%
57
  58.8%
Male
14
  43.8%
14
  40.0%
12
  40.0%
40
  41.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 35 participants 30 participants 97 participants
32 35 30 97
Baseline Pain as measured by validated Visualized Analog Scale (0 to 100 mm)  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 32 participants 35 participants 30 participants 97 participants
91.2  (9.4) 93.2  (8.9) 91.4  (8.5) 91.9  (8.9)
1.Primary Outcome
Title To Compare the Percentage of Subjects Who Achieved Significant Pain Relief Between the 3 Treatment Groups as Measured by a Visual Analog Pain Scale at 60 Minutes A Decrease of at Least 20 mm on the VAS Will be Considered "Significant" Pain Relief
Hide Description The primary endpoint was clinically significant pain relief defined a priori as a decrease in the pain VAS of at least 20 mm from baseline, which was arbitrarily chosen as the minimal amount that may be important to this group of patients and was extrapolated from studies of acute pain management in the ED. Using an effect size of 20-mm change in VAS as the marker for a successful outcome and the proportion of successes by group as the analysis point, we performed a power analysis using three groups: 0.5 mg/kg ketamine, 0.25 mg/kg ketamine, and placebo and found that a sample size of 96 subjects would be required to detect a statistically significant difference among groups with a power of 90% (a = 0.05). Expecting a loss of 10% of subjects due to patient withdrawal or incomplete data, 106 subjects were recruited. Only subjects who completed the 60-minute study and had data recorded for each of the time points were included in the analysis.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine
Hide Arm/Group Description:

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

Overall Number of Participants Analyzed 32 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
13
  40.6%
28
  80.0%
25
  83.3%
2.Secondary Outcome
Title Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine
Hide Description Subjects will be continuously assessed for complications secondary to the sub-dissociative ketamine
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine
Hide Arm/Group Description:

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

Overall Number of Participants Analyzed 32 35 30
Measure Type: Number
Unit of Measure: recorded adverse events
1 14 12
3.Post-Hoc Outcome
Title Follow-up Pain Scores Obtained by Telephone at 24 - 48 Hours
Hide Description Subjects were contacted by phone 24 - 48 hours after the completion of the study infusion. Subjects were asked to score their pain on 10-point numeric rating scale where 0 represented no pain and 10 represented the worst pain they could be having. Pain score was recorded in increments of 1 from 0 - 10. Results were compared between groups using the Mann-Whitney U-test.
Time Frame 24 - 48 hours after study drug infusion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine
Hide Arm/Group Description:

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

Overall Number of Participants Analyzed 30 31 28
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
5
(4 to 8)
5
(4 to 7)
6
(3 to 8)
Time Frame Up to 48 hours after study enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Very Low Dose Ketamine Low Dose Ketamine
Hide Arm/Group Description

placebo controlled arm

Placebo: Normal Saline

0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine

All-Cause Mortality
Placebo Very Low Dose Ketamine Low Dose Ketamine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/35 (0.00%)      0/30 (0.00%)    
Hide Serious Adverse Events
Placebo Very Low Dose Ketamine Low Dose Ketamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      14/35 (40.00%)      12/30 (40.00%)    
Gastrointestinal disorders       
Nausea  [1]  0/32 (0.00%)  0 3/35 (8.57%)  3 3/30 (10.00%)  3
Nervous system disorders       
Dizziness  [2]  1/32 (3.13%)  1 8/35 (22.86%)  8 3/30 (10.00%)  3
Hallucinations  [3]  0/32 (0.00%)  0 0/35 (0.00%)  0 2/30 (6.67%)  2
Anxiety   0/32 (0.00%)  0 0/35 (0.00%)  0 1/30 (3.33%)  1
Anxiety and Dizziness   0/32 (0.00%)  0 1/35 (2.86%)  1 2/30 (6.67%)  2
Anxiety and Palpitations   0/32 (0.00%)  0 1/35 (2.86%)  1 0/30 (0.00%)  0
Dysphoria   0/32 (0.00%)  0 1/35 (2.86%)  1 1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
Patients self-reported feeling nauseated
[2]
Subjects were asked if they felt "dizzy"
[3]
Subjects were assessed for hallucinations
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Very Low Dose Ketamine Low Dose Ketamine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/32 (0.00%)      0/35 (0.00%)      0/30 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Tanen
Organization: Lundquist Institute
Phone: 310-222-3624
EMail: dtanen@emedharbor.edu
Layout table for additonal information
Responsible Party: David Tanen, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT02920528    
Other Study ID Numbers: 30612-01
First Submitted: September 28, 2016
First Posted: September 30, 2016
Results First Submitted: August 8, 2020
Results First Posted: April 15, 2021
Last Update Posted: April 15, 2021