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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study 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

Select...

I am a woman seeking breast reduction for large, heavy breasts.

Select...

I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it presently possible to join in this clinical experiment?

"The clinical trial, which was initially posted on the 1st of January 2020 and last revised April 10th 2022, is currently soliciting participants according to information hosted on clinicaltrials.gov."

Answered by AI

Has Ketorolac obtained the green light from governmental regulators?

"With the drug having been approved, there is a considerable amount of safety data available. Thus, Ketorolac was rated with a score of 3 on our scale."

Answered by AI

What other scientific studies have explored the efficacy of Ketorolac?

"Presently, 38 clinical trials are ongoing for Ketorolac. Out of these investigations, 8 have progressed to the third phase of their trial period. Most research sites for this treatment are based in Los Angeles but a total 57 locations worldwide are running studies with Ketorolac as an intervention."

Answered by AI

What pathologies is Ketorolac typically prescribed for?

"Ketorolac is commonly employed to alleviate ocular irritation, as well as multiple other afflictions such as pain, the stimulation of nerve block, and pupil dilation."

Answered by AI

How many participants are currently registered for this research project?

"Indeed, clinicaltrials.gov reports that this research is currently recruiting. The initial posting was dated January 1st 2020 and the most recent edit occured on April 10th 2022; 100 volunteers are being sought for at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Geethan Chandran 2020. "The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03535116.