Toradol v. Celecoxib for Postoperative Pain (POP)

Michael Ulm, MD

Status and phase: Completed; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Celecoxib; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT03331315

12-02041-FB

Details and patient eligibility

About

Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

Full description

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.

Enrollment: 170 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Ketorolac

Active Comparator group

Description:

Patients receiving scheduled ketorolac postoperatively

Treatment:

Drug: Ketorolac

Celecoxib

Experimental group

Description:

Patients receiving celebrex preoperative and postoperatively for 7 days

Treatment:

Drug: Celecoxib