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Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
Purpose:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Active Comparator | Patients receiving scheduled ketorolac postoperatively |
|
| Celecoxib | Experimental | Patients receiving celebrex preoperative and postoperatively for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Celecoxib | Drug |
| ||
| Ketorolac |
| Measure | Description | Time Frame |
|---|---|---|
| Average Inpatient Postoperative Pain Score | Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff. | 48 hrs following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Average Inpatient Hydromorphone Use | Average inpatient hydromorphone use measured in milligrams | 48 hrs following surgery |
| Average Inpatient Ondansetron Use | Average inpatient ondansetron use measured in milligrams |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Ulm, MD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital System | Memphis | Tennessee | 38104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23945838 | Background | 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. | |
| 28043841 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | Patients receiving scheduled ketorolac postoperatively Ketorolac |
| FG001 | Celecoxib | Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | Patients receiving scheduled ketorolac postoperatively Ketorolac |
| BG001 | Celecoxib | Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Inpatient Postoperative Pain Score | Pain measured using the Visual Analog Scale, no pain (0-0.4 cm), mild pain(0.5-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10.0 cm). Subscale scoring was not used in analysis but provided as reference for patient and nursing staff. | Posted | Mean | Standard Deviation | units on a scale | 48 hrs following surgery |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac | Patients receiving scheduled ketorolac postoperatively Ketorolac |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Kidney Injury | Renal and urinary disorders | Non-systematic Assessment | Transient acute kidney injury, resolved with IV hydration |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Ulm | University of Tennessee - West Cancer Center | 404-281-9480 | mulm@westclinic.com |
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| 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 |
|---|---|
| D000068579 | Celecoxib |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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|
| 48 hrs following surgery |
| Total Hospital Stay | Total hospital stay from time fo admission to time of discharge measured in hours | Following surgery |
| Number of Participants With Perioperative Complications | Perioperative Complications measured intraoperatively and postoperatively by type | During and after surgery |
| Return to Activities of Daily Living | Average number of days required for complete return to independent activities of daily living | 2 weeks after discharge |
| Days of Oral Narcotic Use After Discharge | Measured using postoperative questionnaire | 2 weeks after discharge |
| Number of Oral Narcotic Pills Used After Discharge | Number of oral narcotic pills used after discharge until 2 week postoperative visit. | 2 weeks after discharge |
| 8569017 | Background | 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. |
| 22336956 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | Kg/m^2 |
|
| Surgical Pathology | Count of Participants | Participants |
|
| Procedure | BSO - bilateral salpingo-oophorectomy LND - Lymph Node Dissection Cysto - diagnostic cystoscopy | Count of Participants | Participants |
|
| Operative Time | Mean | Standard Deviation | Minutes |
|
| Trochar Sites | Mean | Standard Deviation | Trochars |
|
| Preoperative Diagnosis | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Average Inpatient Hydromorphone Use | Average inpatient hydromorphone use measured in milligrams | Posted | Mean | Standard Deviation | Milligrams | 48 hrs following surgery |
|
|
|
| Secondary | Average Inpatient Ondansetron Use | Average inpatient ondansetron use measured in milligrams | Posted | Mean | Standard Deviation | Milligrams | 48 hrs following surgery |
|
|
|
| Secondary | Total Hospital Stay | Total hospital stay from time fo admission to time of discharge measured in hours | Posted | Mean | Standard Error | Hours | Following surgery |
|
|
|
| Secondary | Number of Participants With Perioperative Complications | Perioperative Complications measured intraoperatively and postoperatively by type | Posted | Number | Patients | During and after surgery |
|
|
|
| Secondary | Return to Activities of Daily Living | Average number of days required for complete return to independent activities of daily living | Posted | Mean | Standard Deviation | Days | 2 weeks after discharge |
|
|
|
| Secondary | Days of Oral Narcotic Use After Discharge | Measured using postoperative questionnaire | Posted | Mean | Standard Deviation | Days | 2 weeks after discharge |
|
|
|
| Secondary | Number of Oral Narcotic Pills Used After Discharge | Number of oral narcotic pills used after discharge until 2 week postoperative visit. | Posted | Mean | Standard Deviation | Pills | 2 weeks after discharge |
|
|
|
| 0 |
| 70 |
| 1 |
| 70 |
| EG001 | Celecoxib | Patients receiving celebrex preoperative and postoperatively for 7 days Celecoxib | 0 | 68 | 2 | 68 |
|
| Intraoperative Hemorrhage | Blood and lymphatic system disorders | Non-systematic Assessment | Estimated Blood Loss >150cc |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |