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The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery

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ClinicalTrials.gov Identifier: NCT03535116
Recruitment Status : Not yet recruiting
First Posted : May 24, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Geethan Chandran, Dr. Chandran Medical Prof Corp

Brief Summary:
It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for postoperative pain control increases hematoma and bleeding in breast reduction surgery. However, there is no literature that supports this teaching. Ketorolac is used routinely in free flap reconstruction including breast reconstruction as well as many other surgeries including hand surgery without increased risks of hematoma or bleeding. Ketorolac has been shown to give good postoperative pain control. The object of this study is to look at whether ketorolac increases the rate of hematoma/bleeding in breast reduction. If there is no increased risk of hematoma, then ketorolac can be used safely for postoperative pain control with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma rates in a breast reduction are 1-2%.

Condition or disease Intervention/treatment Phase
Hematoma Postoperative Drug: Ketorolac Drug: Saline Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind Randomized Control Trial of breast reduction patients and their postoperative hematoma rates with the use of ketorolac
Masking: Double (Participant, Care Provider)
Masking Description: drug vs placebo(saline). Identification is in a sealed envelope. The anesthetist gives the medication without telling the surgeon or the patient what medication is given(patient will be under a general anesthetic). Neither patient or surgeon will know what the patient gets until the follow up period(6 weeks) is completed.
Primary Purpose: Supportive Care
Official Title: The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A Double Blind Randomized Control Trial
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Patients receiving ketorolac
Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.
Drug: Ketorolac
Toradol is a type of brand name. We will be using the generic version.

Placebo Comparator: Control
Patients receive saline intravenously towards the end of the operation.
Drug: Saline
injectable normal saline




Primary Outcome Measures :
  1. Hematoma [ Time Frame: 6 weeks ]
    Postoperative hematoma



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   must be female as these are surgeries for breast reductions
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age > 18

  • female
  • clinically met criteria for breast reduction(large heavy breasts)

Exclusion Criteria:

  • smokers
  • morbid obesity
  • history of kidney failure
  • allergy to non steroidal anti-inflammatories
  • did not wish or unable to consent to be in the study

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): NCT03535116


Contacts
Contact: Geethan Chandran, MD (306)380-3910 drgeethanchandran@gmail.com
Contact: Stephanie Chandran, RN (306)380-0870 stephchandran@gmail.com

Sponsors and Collaborators
Dr. Chandran Medical Prof Corp

Responsible Party: Geethan Chandran, Assistant Professor, Dr. Chandran Medical Prof Corp
ClinicalTrials.gov Identifier: NCT03535116     History of Changes
Other Study ID Numbers: 33
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Hematoma
Hemorrhage
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