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Toradol v. Celecoxib for Postoperative Pain (POP)

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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

Tracking Information
First Submitted Date  ICMJE April 7, 2015
First Posted Date  ICMJE November 6, 2017
Results First Submitted Date  ICMJE March 29, 2018
Results First Posted Date  ICMJE June 4, 2018
Last Update Posted Date June 29, 2018
Actual Study Start Date  ICMJE September 1, 2013
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
Average Inpatient Postoperative Pain Score [ Time Frame: 48 hrs following surgery ]
Pain measured using the Visual Analog Scale
Change History Complete list of historical versions of study NCT03331315 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2018)
  • Average Inpatient Hydromorphone Use [ Time Frame: 48 hrs following surgery ]
    Average inpatient hydromorphone use measured in milligrams
  • Average Inpatient Ondansetron Use [ Time Frame: 48 hrs following surgery ]
    Average inpatient ondansetron use measured in milligrams
  • Total Hospital Stay [ Time Frame: Following surgery ]
    Total hospital stay from time fo admission to time of discharge measured in hours
  • Number of Participants With Perioperative Complications [ Time Frame: During and after surgery ]
    Perioperative Complications measured intraoperatively and postoperatively by type
  • 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
  • Days of Oral Narcotic Use After Discharge [ Time Frame: 2 weeks after discharge ]
    Measured using postoperative questionnaire
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • Inpatient narcotic use [ Time Frame: 48 hrs following surgery ]
    Measured in milligrams
  • Inpatient antiemetic use [ Time Frame: 48 hrs following surgery ]
    Measured in milligrams
  • Total Hospital Stay [ Time Frame: 48 hrs following surgery ]
    Measured in hours
  • Postoperative Ileus [ Time Frame: 7 days following surgery ]
    Measured by diagnosis
  • Hemorrhage [ Time Frame: During surgery ]
    Estimated blood loss greater than 150mL for robotic procedures and 500mL for open procedures
  • Intraoperative complications [ Time Frame: During surgery ]
    Blood vessel, bowel, bladder or ureteral injury
  • Return to Activities of Daily Living [ Time Frame: 2 weeks after discharge ]
    Measured using postoperative questionnaire
  • Days of Oral Narcotic Use After Discharge [ Time Frame: 2 weeks after discharge ]
    Measured using postoperative questionnaire
  • Number of Oral Narcotic Pills Used After Discharge [ Time Frame: 2 weeks after discharge ]
    Measured using postoperative questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: October 31, 2017)
Adverse events from NSAID administration [ Time Frame: 2 weeks after surgery ]
 
Descriptive Information
Brief Title  ICMJE Toradol v. Celecoxib for Postoperative Pain
Official Title  ICMJE A Randomized Control Trial Study of the Efficacy of Celecoxib Versus Ketorolac for Perioperative Pain Control
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Celecoxib
  • Drug: Ketorolac
Study Arms  ICMJE
  • Active Comparator: Ketorolac
    Patients receiving scheduled ketorolac postoperatively
    Intervention: Drug: Ketorolac
  • Experimental: Celecoxib
    Patients receiving celebrex preoperative and postoperatively for 7 days
    Intervention: Drug: Celecoxib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2018)
170
Original Actual Enrollment  ICMJE
 (submitted: October 31, 2017)
192
Actual Study Completion Date  ICMJE January 1, 2017
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331315
Other Study ID Numbers  ICMJE 12-02041-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Ulm, University of Tennessee Health Science Center
Study Sponsor  ICMJE University of Tennessee Health Science Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael A Ulm, MD University of Tennessee Health Science Center
PRS Account University of Tennessee Health Science Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP