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| ID | Type | Description | Link |
|---|---|---|---|
| NAM-MD-63 |
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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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Pain is a common element of surgery. Opiates (morphine, oxycodone, hydrocodone, methadone, fentanyl) are very helpful in decreasing pain after surgery. Unfortunately, with repeated use opiates lose their effectiveness, such that patients need to utilize more opiates to achieve adequate pain relief - a phenomenon called tolerance. Sometimes tolerance to a pain reliever's effects can develop in just a few hours. It is thought that activation of the N-methyl d-aspartate (NMDA) receptor, a "switch" found on the surface of nerves, is partially responsible for opiate tolerance. Memantine is a medication that limits the activity of NMDA receptors in the brain and spinal cord. It has been used for years to help patients with Alzheimer's Disease. In this study, we will study the effects of memantine when combined with opiate medications to see whether it can increase the effectiveness of opiates for pain after surgery and reduce the side effects caused by opiates (e.g., sedation, nausea, itching).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opiate Naive | Active Comparator | Subjects who have not taken opiate medication in previous 6 weeks before surgery |
|
| Opiate tolerant | Active Comparator | Subjects who have taken opiate medications for the 6 weeks before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | 7 days prior to surgery, start taking 5mg memantine daily; 4 days prior to surgery, increase dose to 5mg twice daily; 2 days prior to surgery, increase dose to 10mg in the morning, and 5 mg in the evening; on the day of surgery, increase dose to 10mg twice daily, and continue on this dose until 14 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in numerical ratings on pain diaries as outpatients (pre and post surgery) | For 1 week pre-surgery, through 2 weeks post-surgery | |
| Daily pain numerical ratings at rest and with movement as inpatients. | Immediately post-surgery until discharge (2-3 days) | |
| Total opiate dose via patient controlled IV hydromorphone | Post-surgery day 1 | |
| Oxycodone dose taken prn | Post-surgery day 2 through 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment group differences in side effects (nausea, itching, sedation, urinary retention following foley catheter discontinuation) | One week pre-surgery through 3 months post-surgery | |
| Changes in cognitive function, assessed with Digit-Symbol Substitution Test and Trail Making Test B |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lydia Stout, BA | Contact | 206-914-9253 | lstout@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Terman, MD, PhD | University of Washington Department of Anesthesiology and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Medical Center | Recruiting | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18806055 | Background | Grande LA, O'Donnell BR, Fitzgibbon DR, Terman GW. Ultra-low dose ketamine and memantine treatment for pain in an opioid-tolerant oncology patient. Anesth Analg. 2008 Oct;107(4):1380-3. doi: 10.1213/ane.0b013e3181733ddd. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2017 | |
| Reset | May 10, 2017 | |
| Release | Mar 24, 2023 | |
| Reset | Apr 18, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2017 | May 10, 2017 | |||
| Mar 24, 2023 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo | Drug | 7 days prior to surgery, start taking one placebo tablet daily; 4 days prior to surgery, increase dose to one placebo tablet twice daily; 2 days prior to surgery, increase dose to 2 placebo tablets in the morning, and one placebo tablet in the evening; on the day of surgery, increase dose to 2 placebo tablets in the morning and 1 placebo tablet in the evening. On the first day after surgery through 14 days after surgery, take 1 placebo tablet twice daily. |
|
| One week pre-surgery, immediately pre-surgery, and post-surgery days 1, 2, 3 |
| Changes in pain and quality of life questionnaire responses (SF-McGill-2, Brief Pain Questionnaire, SF-36 v2) | One week pre-surgery through 3 months post-surgery, particularly as outpatient |
| Apr 18, 2023 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |