An interventional study of Ketamine and Placebos in Pain, Chronic Pain and Hyperalgesia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
The purpose of this study is to compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
We hypothesize that:
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This study's enrollment of 79 is above the median of 42 across 127 interventional studies indexed under Hyperalgesia.
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Inclusion Criteria for Group 1
Inclusion Criteria for Group 2
Exclusion Criteria for all groups:
Subject is pregnant or breast-feeding.
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This group consists of 16 subjects who have chronic pain conditions treated with an opioid regimen. Subjects were randomized to receive a ketamine treatment during the study. They were given an intravenous infusion of ketamine (0.05mg/kg) diluted in 50 ml normal saline over 30 minutes.
Drug: Ketamine
This group consists of 22 subjects who have chronic pain conditions but were not on an opioid regimen over the last 3 months. Subjects were randomized to receive a ketamine treatment during the study. They were given an intravenous infusion of ketamine (0.05mg/kg) diluted in 50 ml normal saline over 30 minutes.
Drug: Ketamine
This group consists of 18 subjects who have chronic pain conditions treated with an opioid regimen. Subjects were randomized to receive a placebo treatment during the study. They were given an intravenous infusion of 50 ml normal saline over 30 minutes.
Drug: Placebos
This group consists of 23 subjects who have chronic pain conditions but were not on an opioid regimen over the last 3 months. Subjects were randomized to receive a placebo treatment during the study. They were given an intravenous infusion of 50 ml normal saline over 30 minutes.
Drug: Placebos
To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
Also known as: Ketalar
To compare pain threshold, pain tolerance, and wind up, as measured by QST, before and after a single dose of ketamine infusion under two clinical conditions: chronic pain patients on opioid therapy and chronic pain patients without opioid therapy.
Also known as: Saline
Change in Temperature of Pain Threshold
We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s. This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C.
Time frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1
Change in Temperature of Pain Tolerance
Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature. This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C.
Time frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1
Change in Duration of Supra-threshold Pain Tolerance
Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded. This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds.
Time frame: Baseline at visit 1, post inufsion at visit 1, and at visit 2 which was 1 week after visit 1
| Milestone | Opioid - Ketamine | Opioid - Placebos | Non-opioid - Ketamine | Non-opioid - Placebos |
|---|---|---|---|---|
| Started | 16 | 18 | 22 | 23 |
| Completed | 12 | 13 | 20 | 17 |
| Not completed | 4 | 5 | 2 | 6 |
| Withdrew: Physician decision | 4 | 4 | 2 | 6 |
| Withdrew: Subject had scheduling issues | 0 | 1 | 0 | 0 |
We measured the change in pain threshold using Quantitative Sensory Testing (QST). QST refers to a set of quantitative testing of individual responses to mechanical, thermal, and/or electrical stimulation. In this study, pain threshold was the thermal stimulation intensity (in°C) first perceived as painful. To measure this, a contact thermode was attached onto the dorsal surface of the forearm. By pressing a computer mouse button, each subject was able to stop stimulation when they first perceived a painful stimulation from the thermode as the temperature increased 1°C/s. This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C.
| Degrees Celsius | Opioid - Ketamine | Opioid - Placebos | Non-opioid - Ketamine | Non-opioid - Placebos |
|---|---|---|---|---|
| Change in Temperature of Pain Threshold | -0.02 ± 0.79 | -0.61 ± 1.79 | -0.61 ± 1.15 | -0.77 ± 1.04 |
Using QST, we measured the change in pain tolerance which was the maximum thermal stimulation intensity (in °C) tolerable. In this test, the subject was instructed to press the computer mouse to stop stimulation when the thermode reached the maximal tolerable temperature. This test was repeated 3 times and an average temperature was calculated. The temperatures could range from a minimum of 0°C to 53°C.
| Degrees Celsius | Opioid - Ketamine | Opioid - Placebo | Non-opioid - Ketamine | Non-opioid - Placebos |
|---|---|---|---|---|
| Change in Temperature of Pain Tolerance | -0.06 ± 1.46 | 0.52 ± 1.33 | -0.42 ± 1.95 | -0.19 ± 1.03 |
Using QST, we detected the duration (seconds) of tolerance to supra-threshold heat pain stimulation. In this test, subjects were asked to tolerate, as long as he or she could, heat stimulation preset at 47°C for a maximum of 60 seconds. They were given the computer mouse to stop the test if they reached their limit before 60 seconds. If they stopped the test before the 60 seconds, the time that they stopped it was recorded. This test was repeated 3 times and an average duration was calculated. The duration could range from a minimum of 0 seconds to a maximum of 60 seconds.
| seconds | Opioid - Ketamine | Opioid - Placebos | Non-opioid - Ketamine | Non-opioid - Placebos |
|---|---|---|---|---|
| Change in Duration of Supra-threshold Pain Tolerance | -5.22 ± 9.96 | 13.81 ± 19.55 | -1.91 ± 7.32 | -0.39 ± 13.25 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid - Ketamine | — | 0/16 (0%) | 0/16 (0%) |
| Opioid - Placebos | — | 0/18 (0%) | 0/18 (0%) |
| Non-opioid - Ketamine | — | 0/22 (0%) | 0/22 (0%) |
| Non-opioid - Placebos | — | 0/23 (0%) | 0/23 (0%) |
| Age, Categorical(Participants) | Opioid - Ketamine | Opioid - Placebos | Non-opioid - Ketamine | Non-opioid - Placebos | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 18 | 22 | 23 | 79 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Opioid - Ketamine | Opioid - Placebos | Non-opioid - Ketamine | Non-opioid - Placebos | Total |
|---|---|---|---|---|---|
| Female | 10 | 8 | 15 | 13 | 46 |
| Male | 6 | 10 | 7 | 10 | 33 |
Plan to share: No
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Massachusetts General Hospital