N/A
N=79
Effect of Ketamine on Opioid-Induced Hyperalgesia
Pain · Chronic Pain · Hyperalgesia
Bottom Line
View on ClinicalTrials.gov: NCT00833755 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Change in Temperature of Pain Threshold — -0.02; -0.61; -0.61; -0.77 Degrees Celsius — p=0.274
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketamine (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Temperature of Pain Threshold |
-0.02; -0.61; -0.61; -0.77 | 0.274 |
| PRIMARY Change in Temperature of Pain Tolerance |
-0.06; 0.52; -0.42; -0.19 | 0.552 |
| PRIMARY Change in Duration of Supra-threshold Pain Tolerance |
-5.22; 13.81; -1.91; -0.39 | 0.004 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria for Group 1
- Subject will be between ages 18 to 65 years.
- Subject has a chronic pain condition for at least three months. This requirement is set in order to avoid the clinical uncertainty of an unstable pain condition and to minimize the study variation. Subjects should have a VAS pain score at 4 or above at the time of study.
- Subject is on a chronic opioid treatment regimen (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for at least three months. There should have been no changes in the type and amount of opioid dose for at least one month. Only patients with a minimal daily dose of at least 60 mg morphine equianalgesic dose will be included.
Inclusion Criteria for Group 2
- Subject who meets the criteria #1 & #2 as listed for Group 1.
- Subject has not been on an opioid regimen for the last three or more months.
Exclusion Criteria for all groups:
- Subject has an altered sensation at the skin site of QST (one of upper extremities).
- Subject has scar tissue or acute injury at the skin site of QST.
- Subject has neurological disease or a condition causing upper extremities or generalized polyneuropathy, such as diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, multiple sclerosis, amyotrophic lateral sclerosis, and post-stroke residual neurological deficits.
- Subject has a diagnosis of renal or liver failure.
- Subject has a diagnosis of unstable angina, congestive heart failure, cardiac arrythmias or myocardial infarction within 1 year.
- Subject is allergic to ketamine.
- Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months or peripheral neurolytic block involving upper extremities within two-months.
- Subject has a confirmed diagnosis of and is under the care of a psychiatrist for major depression disorder, eating disorder; alcohol or drug dependence; or attention deficit hyperactivity disorder. Subject has any history of a confirmed diagnosis of bipolar disorder, schizophrenia, anxiety disorder or a psychotic disorder
- Subject is tested positive on drug urine screening test.
- Subject is pregnant or breast-feeding.
-
Data sourced from ClinicalTrials.gov (NCT00833755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.