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Trial record 22 of 415 for:    KETOROLAC

Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn (KANGAROO)

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ClinicalTrials.gov Identifier: NCT03007381
Recruitment Status : Withdrawn (No funding.)
First Posted : January 2, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Joey Corkum, Nova Scotia Health Authority

Brief Summary:

Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and central nervous system depression post operatively, while still providing adequate pain control for patients. Patients undergoing abdominally based microsurgical breast reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be safely discharged from hospital sooner than their counterparts receiving standard of care.

Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in addition to standard of care, reduce the length of postoperative hospital stay compared with an intravenous sham saline regimen?

Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm, parallel group, superiority, randomized, and double blinded, controlled trial.

Population: The study population includes all females >18 years old post mastectomy consenting to abdominally based microsurgical breast reconstruction.

Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours postoperatively for 72 hours. The comparator will be a sham intravenous administration of normal saline.

Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes include visual analog scale for pain, breakthrough narcotic consumption, surgical drain outputs, hematoma, and other complications.

Sample Size: Available data provided estimates for average length of hospital stay and standard deviation. A minimally clinically significant difference of 1 day was decided on due to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for attrition and efficiency losses, a total of 50 patients (25 per group) will be required for this study.


Condition or disease Intervention/treatment Phase
Breast Cancer Female Drug: Ketorolac Tromethamine Drug: Normal Saline Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Ketorolac tromethamine
Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the ketorolac intervention group, then the participant will receive 30 mg of intravenous (IV) ketorolac tromethamine. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.
Drug: Ketorolac Tromethamine
Intravenous analgesic
Other Name: Toradol

Sham Comparator: Normal Saline
Each patient will undergo mastectomy(ies) if immediate reconstruction is being performed, followed by uni- or bilateral abdominally based free flap harvest, microsurgical anastomoses, and flap inset. If randomized to the control group the patient will be given a sham IV medication. The sham medication will be normal saline at the same volume as ketorolac, which corresponds to 3 ccs. The anaesthetist will give participants their first study drug intravenously at the conclusion of surgery. The participant will then continue to receive their assigned drug every 6 hours for 72 hours, for a total of 13 doses. Patients all receive 1:1 care from nursing staff in the early postoperative period, and their nurse will administer all drugs given on the surgical ward.
Drug: Normal Saline
Sham comparator




Primary Outcome Measures :
  1. Length of hospital stay postoperatively [ Time Frame: measured when the patient leaves the hospital, averages between 3-9 days ]
    recorded in days beginning post operative day number one


Secondary Outcome Measures :
  1. Visual analog scale for pain [ Time Frame: every 6 hours for 72 hours ]
    Standard for for visual analog scale

  2. Narcotic consumption [ Time Frame: 72 hours ]
    Total narcotic consumption over first 72 hours converted to morphine equivalence

  3. Surgical drain output [ Time Frame: 72 hours ]
    Total surgical drain output over first 72 hours

  4. Hematoma [ Time Frame: measured when the patient leaves the hospital, averages between 3-9 days ]
    Any hematoma requiring management in the operating room

  5. Adverse events [ Time Frame: measured when the patient leaves the hospital, averages between 3-9 days ]
    Any infection requiring antibiotics, or flap complications requiring management in the operating room



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

Inclusion Criteria:

  • Patients 18 years of age or older will be offered inclusion if they are scheduled to undergo unilateral or bilateral postmastectomy abdominally based free flap BR postmastectomy, either in a delayed fashion or at the time of initial mastectomy(ies).

Exclusion Criteria:

  • Patients will be excluded if they meet any of the exclusion criteria: male; revision surgery; a planned pedicled flap reconstruction; any previous diagnosis of chronic renal disease, gastric ulcers, or bleeding disorder; acetaminophen, NSAID or specific ketorolac sensitivity or allergy; pregnancy; or opioid tolerance defined as preoperative opioid use greater than 50 mg.

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): NCT03007381


Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Joseph P Corkum, MD NSHA

Additional Information:
Publications:
Responsible Party: Joey Corkum, Physician, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03007381     History of Changes
Other Study ID Numbers: KANGAROO
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
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 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action