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Toradol v. Celecoxib for Postoperative Pain (POP)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Ketorolac
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 reanastomisis.
  • Allergy to any non-steroidal anti-inflammatory drug
  • Cardiac anomaly or disease
  • Congestive Heart Failure

Sites / Locations

  • Methodist Hospital System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ketorolac

Celecoxib

Arm Description

Patients receiving scheduled ketorolac postoperatively

Patients receiving celebrex preoperative and postoperatively for 7 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2015
Last Updated
June 1, 2018
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT03331315
Brief Title
Toradol v. Celecoxib for Postoperative Pain
Acronym
POP
Official Title
A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Active Comparator
Arm Description
Patients receiving scheduled ketorolac postoperatively
Arm Title
Celecoxib
Arm Type
Experimental
Arm Description
Patients receiving celebrex preoperative and postoperatively for 7 days
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Primary Outcome Measure Information:
Title
Average Inpatient Postoperative Pain Score
Description
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
Secondary Outcome Measure Information:
Title
Average Inpatient Hydromorphone Use
Description
Average inpatient hydromorphone use measured in milligrams
Time Frame
48 hrs following surgery
Title
Average Inpatient Ondansetron Use
Description
Average inpatient ondansetron use measured in milligrams
Time Frame
48 hrs following surgery
Title
Total Hospital Stay
Description
Total hospital stay from time fo admission to time of discharge measured in hours
Time Frame
Following surgery
Title
Number of Participants With Perioperative Complications
Description
Perioperative Complications measured intraoperatively and postoperatively by type
Time Frame
During and after surgery
Title
Return to Activities of Daily Living
Description
Average number of days required for complete return to independent activities of daily living
Time Frame
2 weeks after discharge
Title
Days of Oral Narcotic Use After Discharge
Description
Measured using postoperative questionnaire
Time Frame
2 weeks after discharge
Title
Number of Oral Narcotic Pills Used After Discharge
Description
Number of oral narcotic pills used after discharge until 2 week postoperative visit.
Time Frame
2 weeks after discharge

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 reanastomisis. Allergy to any non-steroidal anti-inflammatory drug Cardiac anomaly or disease Congestive Heart Failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Ulm, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Hospital System
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23945838
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.
Results Reference
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PubMed Identifier
28043841
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.
Results Reference
background
PubMed Identifier
8569017
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.
Results Reference
background
PubMed Identifier
22336956
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.
Results Reference
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Toradol v. Celecoxib for Postoperative Pain

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