The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03535116|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2018
Last Update Posted : May 28, 2018
|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|
|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|
Experimental: Patients receiving ketorolac
Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.
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.
injectable normal saline
- Hematoma [ Time Frame: 6 weeks ]Postoperative hematoma
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
|Contact: Geethan Chandran, MD||(306)firstname.lastname@example.org|
|Contact: Stephanie Chandran, RN||(306)email@example.com|