Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2013-09-01
2017-01-01
Brief Summary
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Detailed Description
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To determine if Celebrex (Celecoxib) is as effective as Toradol (Ketorolac) at controlling postoperative pain when given in addition to standard postoperative pain control regimens.
Rationale:
Toradol (Ketorolac) is currently used by many surgeons as adjuvant therapy in addition to standard narcotics in managing immediate postoperative pain. Toradol (Ketorolac) is a non-steroidal anti-inflammatory drug that acts as a non-selective cyclooxygenase (COX), inhibiting COX-1 and COX-2 isoforms. (Toradol) Ketorolac has been associated with significant complications including postoperative bleeding and acute renal insufficiency. Celebrex (Celecoxib) is a selective COX-2 inhibitor that has been associated with adverse cardiovascular outcomes in patients with pre-existing cardiac disease but not with postoperative bleeding or renal insufficiency. Celebrex (Celecoxib) has also been shown to control postoperative pain but has never been compared to Toradol (Ketorolac).
Population:
Patients undergoing hysterectomy on the gynecology oncology service.
Design:
Randomized control trial.
Procedures:
All patients will receive a standard postoperative pain regimen with oral Tylenol (Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Dilaudid (Hydromorphone) as needed.
Randomization: Each participant will be assigned a number using a random number generator for assignment to one of the two postoperative pain regimens:
Arm 1:
Patients ages 18-65 will receive IV Toradol (Ketorolac) 30mg q6 hrs after their operation for 48 hrs or until hospital discharge if patients are discharged home in less than 48 hours after their operation.
\*\*Patients over age 65 will receive IV Toradol (Ketorolac) 15mg q6hrs instead of 30mg
Arm 2:
Patients who will receive oral Celebrex (Celecoxib) 400mg 1 hour prior to their procedure then 200mg oral twice daily for a total of seven days. Patients discharged prior to 7 days will be given a prescription for Celebrex (Celecoxib) to complete a total of 7 days.
Following surgery all patients will be given a postoperative questionnaire at the day of surgery, which was returned at the two week postoperative visit, examining time until return to ADLs, days of narcotic use, and number of narcotic pills used.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ketorolac
Patients receiving scheduled ketorolac postoperatively
Ketorolac
Celecoxib
Patients receiving celebrex preoperative and postoperatively for 7 days
Celecoxib
Interventions
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Celecoxib
Ketorolac
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Peptic Ulcer Disease
* Chronic Renal Disease
* Liver disease
* Alcohol Abuse
* Daily narcotic usage
* Narcotic use 24 hours prior to surgery
* Crohn's Disease
* History of myocardial infarction
* History of stroke
* Preoperative hematocrit less than 24
* Asthma
* Ulcerative Colitis
* Diverticulitis
* Aspirin Allergy
* Sulfonamide Allergy
* Pre-operative pain score of greater than 3
* Patients undergoing procedures that may involve bowel resection or bowel reanastomosis.
* Allergy to any non-steroidal anti-inflammatory drug
* Cardiac anomaly or disease
* Congestive Heart Failure
18 Years
FEMALE
No
Sponsors
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Michael Ulm, MD
OTHER
Responsible Party
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Michael Ulm, MD
Priniciple Investigator
Principal Investigators
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Michael A Ulm, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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Methodist Hospital System
Memphis, Tennessee, United States
Countries
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References
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Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82.
Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.
Other Identifiers
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12-02041-FB
Identifier Type: -
Identifier Source: org_study_id