Toradol v. Celecoxib for Postoperative Pain (POP)
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|ClinicalTrials.gov Identifier: NCT03331315|
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : June 4, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Celecoxib Drug: Ketorolac||Phase 2|
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.
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).
Patients undergoing hysterectomy on the gynecology oncology service.
Randomized control trial.
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:
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
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control|
|Actual Study Start Date :||September 1, 2013|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||January 1, 2017|
Active Comparator: Ketorolac
Patients receiving scheduled ketorolac postoperatively
Patients receiving celebrex preoperative and postoperatively for 7 days
- Average Inpatient Postoperative Pain Score [ Time Frame: 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.
- Average Inpatient Hydromorphone Use [ Time Frame: 48 hrs following surgery ]Average inpatient hydromorphone use measured in milligrams
- Average Inpatient Ondansetron Use [ Time Frame: 48 hrs following surgery ]Average inpatient ondansetron use measured in milligrams
- Total Hospital Stay [ Time Frame: Following surgery ]Total hospital stay from time fo admission to time of discharge measured in hours
- Number of Participants With Perioperative Complications [ Time Frame: During and after surgery ]Perioperative Complications measured intraoperatively and postoperatively by type
- Return to Activities of Daily Living [ Time Frame: 2 weeks after discharge ]Average number of days required for complete return to independent activities of daily living
- Days of Oral Narcotic Use After Discharge [ Time Frame: 2 weeks after discharge ]Measured using postoperative questionnaire
- Number of Oral Narcotic Pills Used After Discharge [ Time Frame: 2 weeks after discharge ]Number of oral narcotic pills used after discharge until 2 week postoperative visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331315
|United States, Tennessee|
|Methodist Hospital System|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||Michael A Ulm, MD||University of Tennessee Health Science Center|