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Intra-operative Ketorolac for Hematoma Rates in Breast Surgery
Phase 4
Recruiting
Research Sponsored by Dr. Chandran Medical Prof Corp
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients who clinically meet criteria for breast reduction (large heavy breasts)
Age > 18
Must not have
Morbid obesity
History of kidney failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
Summary
This trial will study whether the use of ketorolac during breast reduction surgery leads to an increased rate of hematoma or bleeding.
Who is the study for?
This trial is for women over 18 years old who need breast reduction surgery due to large, heavy breasts. It's not suitable for those with morbid obesity, smokers, a history of kidney failure, an inability or unwillingness to consent to the study, or allergies to NSAIDs like ketorolac.
What is being tested?
The study tests if using ketorolac during surgery affects hematoma rates compared to saline. Ketorolac is thought to increase bleeding risks but also provides good pain control. The trial aims to see if it can be used safely without raising hematoma/bleeding risks in breast reductions.
What are the potential side effects?
Ketorolac may cause side effects such as increased risk of bleeding and hematoma formation post-surgery. Other potential side effects include digestive issues and allergic reactions in those sensitive to NSAIDs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman seeking breast reduction for large, heavy breasts.
Select...
I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am extremely overweight.
Select...
I have had kidney failure in the past.
Select...
I am willing and able to give consent to participate in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hematoma
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Patients receiving ketorolacExperimental Treatment1 Intervention
Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.
Group II: ControlPlacebo Group1 Intervention
Patients receive saline intravenously towards the end of the operation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketorolac
2014
Completed Phase 4
~1760
Find a Location
Who is running the clinical trial?
Dr. Chandran Medical Prof CorpLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman seeking breast reduction for large, heavy breasts.I am older than 18 years.I am extremely overweight.I have had kidney failure in the past.I am willing and able to give consent to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Patients receiving ketorolac
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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