Toradol v. Celecoxib for Postoperative Pain
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/1/2018 |
| Start Date: | September 1, 2013 |
| End Date: | January 1, 2017 |
A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
Randomized control trial between ketorolac versus celecoxib for postoperative pain following
hysterectomy.
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 posteroperative pain regimen with oral Tylenol
(Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Diludid
(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.
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 posteroperative pain regimen with oral Tylenol
(Acetaminophen), oral Lortab (Hydrocodone/Acetaminophen) as needed, and IV Diludid
(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.
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
reanastomisis.
- Allergy to any non-steroidal anti-inflammatory drug
- Cardiac anomaly or disease
- Congestive Heart Failure
We found this trial at
1
site
Click here to add this to my saved trials
