Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02920528|
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : April 15, 2021
Last Update Posted : April 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Ketamine Drug: Placebo||Phase 3|
- The informed consent process will be initiated by investigators in the emergency department.
- All potential subjects will be informed that participation in the study could lead to a positive urine drug test that could remain positive for up to a month after the conclusion of the study.
- Female subjects of child bearing age, will have a pregnancy test performed prior to enrollment; any subjects who are pregnant will be excluded from this project.
- Each subject will be asked to grade his/her pain severity on a 100mm non-hatched visual analog scale (VAS) ranging from 0 (no pain) to 100 (worst, maximum pain).
- Each subject will be asked to fill out a baseline pain questionnaire
- Each subject will be placed on monitors for continuous pulse oximetry, Heart Rate, Respiratory Rate, and blood pressure every 5 minutes for the duration of the study of one hour and longer for any patient who needs continued care. The patients temperature will be taken prior to the start of the protocol.
- Each subject will have an intravenous catheter placed.
- Each subject will be sequentially assigned to one of three treatment groups, based on a computer-generated randomization schedule, to receive an intravenous infusion of sub-dissociative Ketamine (0.25mg/kg), sub-dissociative dose Ketamine (0.5mg/kg), or an equal amount of normal saline.
- All medications will be prepared by an emergency department pharmacist and all study medication intravenous bags will be identical in appearance and will be administered by the emergency department nurse caring for the patient who will be blinded to the study drug.
- Each subject will receive lightly tinted sunglasses to wear during the duration of the study to minimize bias as ketamine can evoke a tell-tale short- lived nystagmus
- Each subject will receive the study medication over a 20 minute period via an automated pump. At this point, the subjects will be asked to rate their pain on a VAS and asked if they need additional pain medication that will consist of intravenous hydromorphone with the dose and frequency determined by the discretion of the treating physician and documented on the data collection sheet.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Subdissociative Dose Ketamine for Treatment of Acute Pain in Subjects With Chronic Pain: A Randomized Controlled Trial|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||June 22, 2018|
|Actual Study Completion Date :||September 1, 2019|
Placebo Comparator: Placebo
placebo controlled arm
Other Name: Normal Saline
Experimental: very low dose ketamine
0.25 mg/kg of sub-dissociative ketamine as an experimental arm
Other Name: ketalar
Experimental: low dose ketamine
0.50 mg/kg of sub-dissociative ketamine as an experimental arm
Other Name: ketalar
- 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 [ Time Frame: 60 minutes ]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.
- Assess the Risk for Adverse Events Associated With Sub-dissociative Dose Ketamine [ Time Frame: 1 hour ]Subjects will be continuously assessed for complications secondary to the sub-dissociative ketamine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920528
|United States, California|
|Emergency Department, Harbor-UCLA Medical Center|
|Torrance, California, United States, 90501|
|Principal Investigator:||David Tanen, MD||Los Angeles Biomedical Institute|