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Trial record 83 of 463 for:    KETOROLAC

Risk of Hematoma After Ketorolac Use in Reduction Mammoplasty.

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ClinicalTrials.gov Identifier: NCT03280043
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
McMaster University

Brief Summary:
The investigators hope to answer the question, "does ketorolac increase the risk of hematoma after reduction mammoplasty?" using a case-control study. All patients who developed a hematoma post reduction mammoplasty (cases) at our institution, and match these with women who had an uncomplicated reduction mammoplasty (controls), and then compare frequency of ketorolac exposure between these two groups as the primary outcome. If ketorolac increases the risk of hematoma, one should expect cases to have been exposed to ketorolac more frequently than controls. Based on previously existing literature, the investigators hypothesize that cases and controls will not differ in their ketorolac exposure, that is, ketorolac does not increase the risk of hematoma.

Condition or disease Intervention/treatment
Breast Reduction Reduction Mammoplasty Hematoma Hemorrhage Procedure: Hematoma

Detailed Description:

The electronic health record databases of St. Joseph's Healthcare Hamilton and Hamilton Health Sciences will be searched, using the coding system, for all cases of reduction mammoplasty with post--operative hematoma as a complication. Only hematomas which required return to the operating room for evacuation will be included (i.e. those treated with observation or needle aspiration will be excluded).

Cases are defined as patients suffering a hematoma post reduction mammoplasty will be identified through hospital coding, and matched with controls based on the following criteria: age, body mass index (BMI), pre-existing hypertension, and institution. Controls are defined as patients who had uncomplicated reduction mammoplasty, and will be randomly pulled through retrospective chart review within the same databases, in the same time period (±5 years).

All patient data will be de--identified, and all devices containing patient information will remain on hospital grounds, and be encrypted according to our hospital protocols. The following data will be extracted from patient charts: age, date of surgery, body mass index, surgeon, anesthetist, volume of breast tissue removed per breast, comorbidities, platelet count, coagulation profile, ketorolac and opioid use including dose, timing, frequency, duration, and route of administration of both, time to discharge including length of stay if overnight, comorbidities (including smoking status), American Society of Anesthesiology score, and post--operative usage of drains.

Matching of cases and controls will be performed by the primary investigator (JB), and at the time of matching, the only visible patient information will be the de-identified patient identification (ID) and the four matching variables (ketorolac exposure was not visible).

The frequency of ketorolac exposure between cases and controls will then be reviewed, and the odds ratio (OR) of exposure to ketorolac, with 95% confidence intervals will be calculated. A two by two table will be generated from our data. Since the incidence of hematoma formation after reduction mammoplasty is very low, the odds ratio will closely approximate the relative risk. To evaluate the statistical significance of the ORs, a level of significance of 0.05 will be used. Independent samples t-test will be used to compare continuous demographic data, and Chi-square analysis will be used for ordinal or categorical data between cases and controls.

Sample size was calculated using the POWER program, described by Dupont and Plummer in 1990. A sample size of 25 cases matched with 25 controls (total n = 50) was required from the following data:

  • p0 = 0.32 (approximate rate of ketorolac exposure amongst breast reduction patients from previous literature from Cawthorn et al.)
  • α = 0.05 (chance of type I error)
  • P = 0.8 (power)
  • m = 1 (matching ratio1:1)
  • Ψ = 3.6 (estimated risk ratio of developing hematoma post breast reduction if exposed to ketorolac, Cawthorn et al.)
  • Φ = 0.2 (measurable difference)

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Does Ketorolac Increase the Risk of Hematoma After Reduction Mammoplasty? A Case-control Study.
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : May 20, 2017
Actual Study Completion Date : August 20, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Group/Cohort Intervention/treatment
Cases
Women who underwent reduction mammoplasty and then developed a hematoma which required return to the operating room for evacuation.
Procedure: Hematoma
Hematoma requiring return to operating room.

Controls
Women who had uncomplicated reduction mammoplasty.



Primary Outcome Measures :
  1. Ketorolac exposure. [ Time Frame: Sept 2015 - Aug 2017. ]
    Whether or not cases and controls were exposed to ketorolac on the day of surgery will be determined and compiled as a categorical variable (yes/no).


Secondary Outcome Measures :
  1. Year of reduction mammoplasty. [ Time Frame: Sept 2015 - Aug 2017. ]
    The year of which the reduction mammoplasty occurred will be recorded for cases and controls. The investigators will then calculate the mean year which the reduction mammoplasty surgery occurred for the case and control groups, to ensure that on average, each group is similar in terms of the year the surgeries occurred.

  2. Age of patients in each group will be calculated. [ Time Frame: Sept 2015 - Aug 2017. ]
    Age, extracted from the medical chart, will be aggregated and mean age for cases and controls will be calculated.

  3. Body mass index compared between cases and controls. [ Time Frame: Sept 2015 - Aug 2017. ]
    BMI will be calculated for each patient from height and weight available in the medical chart, and mean BMI between case and control groups will be compared.

  4. Volume of breast tissue resected during surgery (in grams) for each patient. [ Time Frame: Sept 2015 - Aug 2017. ]
    Mean volume of breast tissue resected from each breast, which is a routinely recorded number during reduction mammoplasty, will be extracted for each patient, and mean volumes resected will be compared between cases and controls.

  5. Pre-operative platelet count. [ Time Frame: Sept 2015 - Aug 2017. ]
    Platelet counts, if available, will be extracted for each patient and means for cases and controls will be compared.

  6. Smoking status. [ Time Frame: Sept 2015 - Aug 2017. ]
    Active smokers (yes/no) will be determined by reviewing the pre-operative anesthesia records which routinely contain this information.

  7. American society of anesthesiologist (ASA) score. [ Time Frame: Sept 2015 - Aug 2017. ]
    This is an ordinal score (ASA 1 through 4) given to all patients pre-operatively, as a general indicator of risk of morbidity and mortality with a general anesthetic. This will be extracted for each patient from the pre-operative anesthesia records and frequencies of patients who are ASA 1, ASA 2, ASA 3, or ASA 4 will be aggregated and compared between cases and controls.

  8. Specific breast side of hematoma occurrence (left versus right). [ Time Frame: Sept 2015 - Aug 2017. ]
    In patients who developed a hematoma (cases), the investigators will record whether this occurred on the left, right, or both breasts.

  9. Post-operative opioid consumption. [ Time Frame: Sept 2015 - Aug 2017. ]
    The investigators will calculate post-operative opioid consumption for each patient in the study. Values will be converted to equivalence of oral morphine, in milligrams, using standard conversion charts. Mean opioid consumption will be compared between patients who received ketorolac and those who did not.

  10. Surgeon's description of bleeding encountered during hematoma take-back. [ Time Frame: Sept 2015 - Aug 2017. ]
    The investigators will review transcribed dictations of the surgeon for hematoma cases in order to determine what type of bleeding was encountered during take-back surgery. The categorical descriptors will be: pulsatile bleeding, general ooze, or both. The investigators will compare descriptors between patients who received ketorolac and those who did not.

  11. Ketorolac dose. [ Time Frame: Sept 2015 - Aug 2017. ]
    Amongst cases and controls who received ketorolac, the specific dose of ketorolac given will be recorded in milligrams.

  12. Ketorolac route given. [ Time Frame: Sept 2015 - Aug 2017. ]
    Amongst cases and controls who received ketorolac, the route which ketorolac was given will be recorded as a categorical variable (intra-venous, intra-muscular, or oral).

  13. Timing of ketorolac dose. [ Time Frame: Sept 2015 - Aug 2017. ]
    Amongst cases and controls who received ketorolac, the timing of the dose given will be recorded (i.e. pre-operative, intra-operative, or post-operative).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Medical coders will identify all possible cases of hematoma by searching the key words "hemorrhage," "hematoma," and "plastic surgery". Hematomas post reduction mammoplasty will be manually retrieved and reviewed. Control patients will be randomly pulled from the database of uncomplicated reduction mammoplasties.
Criteria

Inclusion Criteria:

Cases:

- Patients who developed hematoma post-reduction mammoplasty requiring repeat surgery

Controls:

- Uncomplicated bilateral reduction mammoplasty

Exclusion Criteria:

  • Hematoma patients treated with observation or needle aspiration
  • Concomitant surgeries in addition to the reduction mammoplasty
  • Allergy/sensitivity to non-steroidal anti-inflammatory drugs
  • Unilateral reduction mammoplasty
  • Male reduction mammoplasty
  • Documented bleeding disorders

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): NCT03280043


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Achilleas Thoma, MD, MSc, BSc McMaster University

Publications:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03280043     History of Changes
Other Study ID Numbers: 1094-C
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by McMaster University:
Breast reduction
Reduction mammoplasty
Hematoma
Hemorrhage
Ketorolac
Toradol

Additional relevant MeSH terms:
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Ketorolac
Ketorolac Tromethamine
Hemorrhage
Hematoma
Pathologic Processes
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