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We were not able to enroll patients.
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The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone fracture.
This will be a prospective, randomized, control trial looking at the benefit of bimodal analgesia in the treatment of long bone fractures. The traditional pain control regimen following fracture fixation typically involves a course of narcotics on an as-needed basis for pain relief. Recent data has shown that adding NSAIDS to the pain regimen as part of a bimodal approach to pain control, improves the efficacy of pain management and reduces narcotic use. Laboratory research on NSAIDs as it pertains to bone healing, however, has shown in animal models that there may be a positive association between NSAIDS and non-union rates. In other words, NSAIDS may prevent or delay bone healing. These results, however, have not been tested prospectively in humans.
The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Narcotics alone | Drug | |||
| Narcotics and NSAIDS | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| pain score | ||
| Amount of narcotics used | ||
| time to fracture healing |
| Measure | Description | Time Frame |
|---|---|---|
| return to activity | ||
| complications | ||
| reoperation rate |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars C Richardson, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11091128 | Background | Dumont AS, Verma S, Dumont RJ, Hurlbert RJ. Nonsteroidal anti-inflammatory drugs and bone metabolism in spinal fusion surgery: a pharmacological quandary. J Pharmacol Toxicol Methods. 2000 Jan-Feb;43(1):31-9. doi: 10.1016/s1056-8719(00)00077-0. | |
| 12440488 | Background | Aspenberg P. Avoid cox inhibitors after skeletal surgery! Acta Orthop Scand. 2002 Oct;73(5):489-90. doi: 10.1080/000164702321022730. No abstract available. |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| D005264 | Femoral Fractures |
| D006810 | Humeral Fractures |
| D050723 | Fractures, Bone |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D001134 | Arm Injuries |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D009294 | Narcotics |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 14763714 | Background | Allami MK, Giannoudis PV. Cox inhibitors and bone healing. Acta Orthop Scand. 2003 Dec;74(6):771-2. doi: 10.1080/00016470310018351. No abstract available. |
| 14711953 | Background | Brown KM, Saunders MM, Kirsch T, Donahue HJ, Reid JS. Effect of COX-2-specific inhibition on fracture-healing in the rat femur. J Bone Joint Surg Am. 2004 Jan;86(1):116-23. doi: 10.2106/00004623-200401000-00017. |
| 10963160 | Background | Giannoudis PV, MacDonald DA, Matthews SJ, Smith RM, Furlong AJ, De Boer P. Nonunion of the femoral diaphysis. The influence of reaming and non-steroidal anti-inflammatory drugs. J Bone Joint Surg Br. 2000 Jul;82(5):655-8. doi: 10.1302/0301-620x.82b5.9899. |
| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D018712 | Analgesics, Non-Narcotic |
| D000893 | Anti-Inflammatory Agents |
| D018501 | Antirheumatic Agents |