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Sponsored by: |
Massachusetts General Hospital |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00833755 |
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.
Condition | Intervention |
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Pain Chronic Pain Hyperalgesia |
Drug: Ketamine |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Effect of Ketamine on Opioid-Induced Hyperalgesia |
Estimated Enrollment: | 136 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Group 1: 90 subjects who have chronic pain conditions treated with an opioid regimen. Subjects will be randomized to receive either a ketamine (45 subjects) or a placebo (45 subjects) treatment during the study. Group2: This group will include 46 subjects who have chronic pain conditions similar to those in Group 1 but not on an opioid regimen over the last 3 months. Subjects in this group also will be randomized to receive either ketamine (23 subjects) or a placebo (23 subjects) treatment.
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Drug: Ketamine
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.
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2 |
Drug: Ketamine
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.
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We hypothesize that:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Subjects with chronic pain
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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Contact: Mary Houghton, B.A. | 617-726-3744 | mhoughton1@partners.org |
Contact: Charlene Malarick, R.N. | 617-724-0253 | cmalarick@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Principal Investigator: Jianren Mao, M.D., Ph.D. |
Principal Investigator: | Jianren Mao, M.D., Ph.D. | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Dr. Jianren Mao, Principal Investigator ) |
Study ID Numbers: | 2008-P-000879 |
Study First Received: | January 29, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00833755 History of Changes |
Health Authority: | United States: Institutional Review Board |
Pain Chronic pain Opioid induced hyperalgesia Opioid therapy |
Anesthetics, Intravenous Excitatory Amino Acids Sensation Disorders Neurotransmitter Agents Central Nervous System Depressants Anesthetics Pain Hyperalgesia Anesthetics, Dissociative |
Somatosensory Disorders Signs and Symptoms Anesthetics, General Ketamine Neurologic Manifestations Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Anesthetics, Intravenous Sensation Disorders Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Hyperalgesia Pharmacologic Actions Anesthetics, Dissociative |
Somatosensory Disorders Signs and Symptoms Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Neurologic Manifestations Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Excitatory Amino Acid Antagonists |