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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The purpose of this study is to determine whether administration of pregabalin by mouth immediately preoperatively and three times daily for 3 days after surgery reduces the incidence of delirium postoperatively and improves overall pain control.
Delirium is a common postoperative complication occurring in up to 73% of patients sometime during their hospital stay. Elderly patients undergoing major surgical procedures are at highest risk. While many risk factors for delirium are known, the specific pathophysiology of postoperative delirium remains unclear and is likely multifactorial. The most common inciting agents and events include metabolic causes, medications, blood loss, hypoxemia and pain. Pain and its management are intimately related to the likelihood of developing postoperative delirium. As a class, gabapentinoids, such as pregabalin, have proven to reduce postoperative pain and narcotic consumption and therefore may have a role to play in the prevention of postoperative delirium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugar pill | Placebo Comparator | Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively |
|
| Pregabalin | Experimental | Single dose of 75 mg given 30-60 minutes preoperatively, then 50 mg every 8 hours for 3 days postoperatively if creatinine clearance > 60 ml/min OR 25 mg every 8 hours for 3 days postoperatively if creatinine clearance 30-60 ml/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug | Pregabalin capsule 75 mg given preoperatively, then eith 50 mg or 25 mg given every 8 hours for 3 days postoperatively based on renal function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delirium (patient is either CAM-ICU positive or positive for delirium by chart review) | postoperative day 1, 2, 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Interference with daily activities using BPI | postoperative day 3 | |
| Pain at rest using NRS | postoperative days 1, 2, 3 | |
| Pain with movement of the operative site using NRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan J Chaput, MD, MSc | The Ottawa Hospital | Principal Investigator |
| Homer Yang, MD | The Ottawa Hospital | Study Director |
| Gregory L Bryson, MD, MSc | The Ottawa Hospital | Study Director |
| Holly Evans, MD | The Ottawa Hospital | Study Director |
| Paul Beaule, MD | The Ottawa Hospital | Study Director |
| Prasad Jetty, MD | The Ottawa Hospital | Study Director |
| Barbara Power, MD | The Ottawa Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2240918 | Background | Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941. | |
| 15370579 | Background | Bitsch M, Foss N, Kristensen B, Kehlet H. Pathogenesis of and management strategies for postoperative delirium after hip fracture: a review. Acta Orthop Scand. 2004 Aug;75(4):378-89. doi: 10.1080/00016470410001123. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 31, 2017 | |
| Reset | Mar 20, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 31, 2017 | Mar 20, 2017 |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Sugar pill | Other | Single dose given 30-60 minutes preoperatively, then given every 8 hours for 3 days postoperatively |
|
| postoperative days 1, 2, 3 |
| Narcotic analgesic requirements | postoperative days 0, 1, 2, 3 |
| Sedation using RSS | postoperative days 1, 2, 3 |
| Narcotic-related adverse effects using ORSDS | postoperative days 1, 2, 3 |
| Recovery using the QoR | postoperative day 3 |
| Length of stay | Discharge day |
| Medical Outcome Study (MOS) sleep score | Postoperative day 3 |
| 12560416 | Background | Morrison RS, Magaziner J, Gilbert M, Koval KJ, McLaughlin MA, Orosz G, Strauss E, Siu AL. Relationship between pain and opioid analgesics on the development of delirium following hip fracture. J Gerontol A Biol Sci Med Sci. 2003 Jan;58(1):76-81. doi: 10.1093/gerona/58.1.m76. |
| 12817919 | Background | Bekker AY, Weeks EJ. Cognitive function after anaesthesia in the elderly. Best Pract Res Clin Anaesthesiol. 2003 Jun;17(2):259-72. doi: 10.1016/s1521-6896(03)00005-3. |
| 9539601 | Background | Lynch EP, Lazor MA, Gellis JE, Orav J, Goldman L, Marcantonio ER. The impact of postoperative pain on the development of postoperative delirium. Anesth Analg. 1998 Apr;86(4):781-5. doi: 10.1097/00000539-199804000-00019. |
| 16738290 | Background | Gilron I. Review article: the role of anticonvulsant drugs in postoperative pain management: a bench-to-bedside perspective. Can J Anaesth. 2006 Jun;53(6):562-71. doi: 10.1007/BF03021846. |
| 17505569 | Background | Peng PW, Wijeysundera DN, Li CC. Use of gabapentin for perioperative pain control -- a meta-analysis. Pain Res Manag. 2007 Summer;12(2):85-92. doi: 10.1155/2007/840572. |
| 16914695 | Background | Leung JM, Sands LP, Rico M, Petersen KL, Rowbotham MC, Dahl JB, Ames C, Chou D, Weinstein P. Pilot clinical trial of gabapentin to decrease postoperative delirium in older patients. Neurology. 2006 Oct 10;67(7):1251-3. doi: 10.1212/01.wnl.0000233831.87781.a9. Epub 2006 Aug 16. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002241 | Carbohydrates |