Clinical trial NCT03331315: Toradol v. Celecoxib for Postoperative Pain
Official title: A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain, Postoperative
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Inpatient Postoperative Pain Score
timeFrame: 48 hrs following surgery
Secondary outcomes:
measure: Average Inpatient Hydromorphone Use
timeFrame: 48 hrs following surgery
measure: Average Inpatient Ondansetron Use
timeFrame: 48 hrs following surgery
measure: Total Hospital Stay
timeFrame: Following surgery
measure: Number of Participants With Perioperative Complications
timeFrame: During and after surgery
measure: Return to Activities of Daily Living
timeFrame: 2 weeks after discharge
measure: Days of Oral Narcotic Use After Discharge
timeFrame: 2 weeks after discharge
measure: Number of Oral Narcotic Pills Used After Discharge
timeFrame: 2 weeks after discharge
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Methodist Hospital System
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Michael A Ulm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
citation: Blanton E, Lamvu G, Patanwala I, Barron KI, Witzeman K, Tu FF, As-Sanie S. Non-opioid pain management in benign minimally invasive hysterectomy: A systematic review. Am J Obstet Gynecol. 2017 Jun;216(6):557-567. doi: 10.1016/j.ajog.2016.12.175. Epub 2016 Dec 30.
citation: Strom BL, Berlin JA, Kinman JL, Spitz PW, Hennessy S, Feldman H, Kimmel S, Carson JL. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding. A postmarketing surveillance study. JAMA. 1996 Feb 7;275(5):376-82.
citation: Gong L, Thorn CF, Bertagnolli MM, Grosser T, Altman RB, Klein TE. Celecoxib pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Apr;22(4):310-8. doi: 10.1097/FPC.0b013e32834f94cb. No abstract available.