Pain, Postoperative
Conditions
Brief summary
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
Detailed 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.
Interventions
DRUGCelecoxib
DRUGKetorolac
Sponsors
Michael Ulm, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Inpatient Postoperative Pain Score | 48 hrs following surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Inpatient Ondansetron Use | 48 hrs following surgery | Average inpatient ondansetron use measured in milligrams |
| Average Inpatient Hydromorphone Use | 48 hrs following surgery | Average inpatient hydromorphone use measured in milligrams |
| Number of Participants With Perioperative Complications | During and after surgery | Perioperative Complications measured intraoperatively and postoperatively by type |
| Total Hospital Stay | Following surgery | Total hospital stay from time fo admission to time of discharge measured in hours |
| Days of Oral Narcotic Use After Discharge | 2 weeks after discharge | Measured using postoperative questionnaire |
| Number of Oral Narcotic Pills Used After Discharge | 2 weeks after discharge | Number of oral narcotic pills used after discharge until 2 week postoperative visit. |
| Return to Activities of Daily Living | 2 weeks after discharge | Average number of days required for complete return to independent activities of daily living |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Patients receiving scheduled ketorolac postoperatively
Ketorolac | 70 |
| Celecoxib Patients receiving celebrex preoperative and postoperatively for 7 days
Celecoxib | 68 |
| Total | 138 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 18 | 14 |
Baseline characteristics
| Characteristic | Celecoxib | Total | Ketorolac |
|---|---|---|---|
| Age, Continuous | 55.1 years STANDARD_DEVIATION 14.4 | 55.7 years STANDARD_DEVIATION 12 | 56.3 years STANDARD_DEVIATION 11.3 |
| Body Mass Index | 31.7 Kg/m^2 STANDARD_DEVIATION 8.1 | 31.7 Kg/m^2 STANDARD_DEVIATION 8.3 | 31.8 Kg/m^2 STANDARD_DEVIATION 8.6 |
| Operative Time | 104 Minutes STANDARD_DEVIATION 34 | 104 Minutes STANDARD_DEVIATION 33 | 105 Minutes STANDARD_DEVIATION 32 |
| Preoperative Diagnosis Abnormal Uterine Bleeding | 8 Participants | 11 Participants | 3 Participants |
| Preoperative Diagnosis Adnexal Mass | 14 Participants | 24 Participants | 10 Participants |
| Preoperative Diagnosis Genetic Predisposition to Malignancy | 4 Participants | 7 Participants | 3 Participants |
| Preoperative Diagnosis Leiomyoma | 4 Participants | 12 Participants | 8 Participants |
| Preoperative Diagnosis Malignancy | 15 Participants | 36 Participants | 21 Participants |
| Preoperative Diagnosis Pelvic Pain | 8 Participants | 19 Participants | 11 Participants |
| Preoperative Diagnosis Premalignancy | 15 Participants | 29 Participants | 14 Participants |
| Procedure Robotic Assisted Hysterectomy, +/- BSO, Cysto | 53 Participants | 101 Participants | 48 Participants |
| Procedure Robotic Assisted Hysterectomy, +/- BSO, LND, Cysto | 15 Participants | 37 Participants | 22 Participants |
| Sex: Female, Male Female | 68 Participants | 138 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical Pathology Benign | 53 Participants | 101 Participants | 48 Participants |
| Surgical Pathology Malignant | 15 Participants | 37 Participants | 22 Participants |
| Trochar Sites | 4.2 Trochars STANDARD_DEVIATION 0.4 | 4.2 Trochars STANDARD_DEVIATION 0.5 | 4.3 Trochars STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 70 | 2 / 68 |
| serious Total, serious adverse events | 0 / 70 | 0 / 68 |
Outcome results
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.
Time frame: 48 hrs following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Average Inpatient Postoperative Pain Score | 2.7 units on a scale | Standard Deviation 1.9 |
| Celecoxib | Average Inpatient Postoperative Pain Score | 2.4 units on a scale | Standard Deviation 1.6 |
Secondary
Average Inpatient Hydromorphone Use
Average inpatient hydromorphone use measured in milligrams
Time frame: 48 hrs following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Average Inpatient Hydromorphone Use | 0.7 Milligrams | Standard Deviation 1 |
| Celecoxib | Average Inpatient Hydromorphone Use | 0.8 Milligrams | Standard Deviation 1 |
Secondary
Average Inpatient Ondansetron Use
Average inpatient ondansetron use measured in milligrams
Time frame: 48 hrs following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Average Inpatient Ondansetron Use | 1.5 Milligrams | Standard Deviation 1.9 |
| Celecoxib | Average Inpatient Ondansetron Use | 1.3 Milligrams | Standard Deviation 2.2 |
Secondary
Days of Oral Narcotic Use After Discharge
Measured using postoperative questionnaire
Time frame: 2 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Days of Oral Narcotic Use After Discharge | 5.7 Days | Standard Deviation 2.8 |
| Celecoxib | Days of Oral Narcotic Use After Discharge | 3.8 Days | Standard Deviation 2.6 |
Secondary
Number of Oral Narcotic Pills Used After Discharge
Number of oral narcotic pills used after discharge until 2 week postoperative visit.
Time frame: 2 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Number of Oral Narcotic Pills Used After Discharge | 8.1 Pills | Standard Deviation 4 |
| Celecoxib | Number of Oral Narcotic Pills Used After Discharge | 6.0 Pills | Standard Deviation 3.6 |
Secondary
Number of Participants With Perioperative Complications
Perioperative Complications measured intraoperatively and postoperatively by type
Time frame: During and after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ketorolac | Number of Participants With Perioperative Complications | 5 Patients |
| Celecoxib | Number of Participants With Perioperative Complications | 6 Patients |
Secondary
Return to Activities of Daily Living
Average number of days required for complete return to independent activities of daily living
Time frame: 2 weeks after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Return to Activities of Daily Living | 2.4 Days | Standard Deviation 0.8 |
| Celecoxib | Return to Activities of Daily Living | 2.2 Days | Standard Deviation 0.9 |
Secondary
Total Hospital Stay
Total hospital stay from time fo admission to time of discharge measured in hours
Time frame: Following surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Total Hospital Stay | 11.6 Hours | Standard Error 8.1 |
| Celecoxib | Total Hospital Stay | 11.9 Hours | Standard Error 7.6 |