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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.Check my eligibility
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.See study design
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 below
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I am a woman seeking breast reduction for large, heavy breasts.
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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.
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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 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

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

Ketorolac Clinical Trial Eligibility Overview. Trial Name: NCT03535116 — Phase 4
Hematoma Research Study Groups: Control, Patients receiving ketorolac
Hematoma Clinical Trial 2023: Ketorolac Highlights & Side Effects. Trial Name: NCT03535116 — Phase 4
Ketorolac 2023 Treatment Timeline for Medical Study. Trial Name: NCT03535116 — Phase 4
~8 spots leftby Dec 2024
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