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Completed

NCT Number: NCT03331315

Toradol v. Celecoxib for Postoperative Pain

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Methodist Hospital System

Memphis, Tennessee, 38104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib

Drug

Ketorolac

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Michael Ulm, MD

Other

Registry information

Official study title

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

Acronym: POP

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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