Toradol v. Celecoxib for Postoperative Pain

Study Overview
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Brief Summary
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Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

Detailed Description
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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.

Official Title
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A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Celecoxib
* Drug: Ketorolac


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing hysterectomy Exclusion Criteria: Coronary Artery Disease 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac<br>Patients receiving scheduled ketorolac postoperatively | Drug: Ketorolac<br> <br> |
| Experimental: Celecoxib<br>Patients receiving celebrex preoperative and postoperatively for 7 days | Drug: Celecoxib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |