Methodist Hospital System
Memphis, Tennessee, 38104, United States
NCT Number: NCT03331315
Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.
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Notify Me18 year and older
Female
Interventional
Phase 2
Memphis, Tennessee, 38104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 48 hrs following surgery
Average inpatient hydromorphone use measured in milligrams
Time frame: 48 hrs following surgery
Average inpatient ondansetron use measured in milligrams
Time frame: Following surgery
Total hospital stay from time fo admission to time of discharge measured in hours
Time frame: During and after surgery
Perioperative Complications measured intraoperatively and postoperatively by type
Time frame: 2 weeks after discharge
Average number of days required for complete return to independent activities of daily living
Time frame: 2 weeks after discharge
Measured using postoperative questionnaire
Time frame: 2 weeks after discharge
Number of oral narcotic pills used after discharge until 2 week postoperative visit.
Michael Ulm, MD
Other
A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
Acronym: POP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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