Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Toradol v. Celecoxib for Postoperative Pain (POP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03331315
Recruitment Status : Completed
First Posted : November 6, 2017
Results First Posted : June 4, 2018
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Ulm, University of Tennessee Health Science Center

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Celecoxib Drug: Ketorolac Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ketorolac
Patients receiving scheduled ketorolac postoperatively
Drug: Ketorolac
Experimental: Celecoxib
Patients receiving celebrex preoperative and postoperatively for 7 days
Drug: Celecoxib



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Average Inpatient Hydromorphone Use [ Time Frame: 48 hrs following surgery ]
    Average inpatient hydromorphone use measured in milligrams

  2. Average Inpatient Ondansetron Use [ Time Frame: 48 hrs following surgery ]
    Average inpatient ondansetron use measured in milligrams

  3. Total Hospital Stay [ Time Frame: Following surgery ]
    Total hospital stay from time fo admission to time of discharge measured in hours

  4. Number of Participants With Perioperative Complications [ Time Frame: During and after surgery ]
    Perioperative Complications measured intraoperatively and postoperatively by type

  5. 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

  6. Days of Oral Narcotic Use After Discharge [ Time Frame: 2 weeks after discharge ]
    Measured using postoperative questionnaire

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Tennessee
Methodist Hospital System
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
University of Tennessee Health Science Center
Investigators
Layout table for investigator information
Principal Investigator: Michael A Ulm, MD University of Tennessee Health Science Center

Publications:
Layout table for additonal information
Responsible Party: Michael Ulm, Priniciple Investigator, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT03331315     History of Changes
Other Study ID Numbers: 12-02041-FB
First Posted: November 6, 2017    Key Record Dates
Results First Posted: June 4, 2018
Last Update Posted: June 29, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Layout table for MeSH terms
Ketorolac
Ketorolac Tromethamine
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action