Toradol v. Celecoxib for Postoperative Pain

Pain, Postoperative Clinical Trial

— POP  

Official title:

A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03331315
• Other study ID #: 12-02041-FB
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2013
• Est. completion date: January 1, 2017

Study information

• Verified date: November 2023
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized control trial between ketorolac versus celecoxib for postoperative pain following hysterectomy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 1, 2017
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Celecoxib

• Ketorolac

Locations

Country	Name	City	State
United States	Methodist Hospital System	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Michael Ulm, MD

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	48 hrs following surgery
Secondary	Average Inpatient Hydromorphone Use	Average inpatient hydromorphone use measured in milligrams	48 hrs following surgery
Secondary	Average Inpatient Ondansetron Use	Average inpatient ondansetron use measured in milligrams	48 hrs following surgery
Secondary	Total Hospital Stay	Total hospital stay from time fo admission to time of discharge measured in hours	Following surgery
Secondary	Number of Participants With Perioperative Complications	Perioperative Complications measured intraoperatively and postoperatively by type	During and after surgery
Secondary	Return to Activities of Daily Living	Average number of days required for complete return to independent activities of daily living	2 weeks after discharge
Secondary	Days of Oral Narcotic Use After Discharge	Measured using postoperative questionnaire	2 weeks after discharge
Secondary	Number of Oral Narcotic Pills Used After Discharge	Number of oral narcotic pills used after discharge until 2 week postoperative visit.	2 weeks after discharge