Intra-operative Ketorolac for Hematoma Rates in Breast Surgery

Overseen By Geethan Chandran, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Dr. Chandran Medical Prof Corp

Must not be taking: Non steroidal anti-inflammatories

Disqualifiers: Smokers, Morbid obesity, Kidney failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketorolac, a pain relief medication, increases the chance of bleeding or bruising (hematoma) during breast reduction surgery. Traditionally, some have believed it raises bleeding risks, but evidence does not support this. Participants will receive either ketorolac or a placebo (a harmless, inactive substance) to compare outcomes. Women with large, heavy breasts considering breast reduction surgery might be suitable candidates, provided they do not smoke or have certain health issues like kidney problems. The study aims to ensure safe and effective pain management for future patients. As a Phase 4 trial, this research involves an FDA-approved treatment to better understand its benefits for more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for ketorolac?

Research has shown that ketorolac is generally well-tolerated in various surgeries. In breast free flap surgeries, the occurrence of hematomas (bruises from bleeding) was 5.3% for both those who received ketorolac and those who did not. A study involving 3,384 patients across six different studies found no clear evidence that ketorolac increased the risk of hematomas. However, one study suggested a possible increase in risk, with a 2.4 times higher chance, but this finding wasn't strong enough to be conclusive.

Ketorolac is already approved for pain relief in other surgeries without increasing bleeding. It also reduces the need for opioids (strong painkillers) after surgery. Overall, ketorolac has been shown to be safe for managing pain in various surgeries, but more research is needed to confirm its safety in breast reduction surgery specifically. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for reducing hematoma rates in breast surgery, which often involves careful surgical techniques and postoperative monitoring, ketorolac offers a pharmacological approach. Ketorolac is an anti-inflammatory drug that works by blocking the production of certain natural substances in your body that cause inflammation. Researchers are excited about ketorolac because it can be administered intravenously during the operation, potentially reducing hematoma without the need for additional surgical intervention. This approach could simplify postoperative care and improve recovery times for patients.

What evidence suggests that ketorolac is effective for reducing hematoma rates in breast surgery?

Research has shown that ketorolac, which participants in this trial may receive, helps manage pain after surgery. One study found that patients who received ketorolac needed fewer opioids and experienced less pain post-operation. However, concerns exist about ketorolac potentially increasing the risk of hematomas, or blood pooling under the skin, during breast reduction surgery. Specifically, one study found that patients taking ketorolac were 2.4 times more likely to develop a hematoma. Another study also reported a higher rate of hematomas in patients using ketorolac compared to those who did not. Despite these findings, ketorolac is often used in various surgeries without causing additional bleeding problems. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am older than 18 years.

Exclusion Criteria

Smokers

Allergy to non-steroidal anti-inflammatories

I am extremely overweight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo breast reduction surgery with either ketorolac or placebo administered intra-operatively

1 day

1 visit (in-person)

Follow-up

Participants are monitored for hematoma and pain levels postoperatively

6 weeks

2 visits (in-person) at 2 weeks and 6 weeks postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients receiving ketorolac Experimental Treatment 1 Intervention

Patient receives 30mg IV ketorolac(single dose) towards the end of the operation.

Group II: Control Placebo Group 1 Intervention

Patients receive saline intravenously towards the end of the operation.

Who Is Running the Clinical Trial?

Dr. Chandran Medical Prof Corp

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03535116

The Effect of Intra-operative Ketorolac on Hematoma Rates ... 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/ ...

2. journals.lww.com journals.lww.com/10.1097/01.GOX.0001114032.36882.f1

47. Does Ketorolac Increase Hematoma Risk in Breast... Breast reduction patients who received ketorolac had a significantly higher rate of hematoma compared to those who did not receive ketorolac (1.39% vs. 0.72%, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11832206/

A Double-blinded Prospective Randomized Controlled Trial This study demonstrates that a single dose of intraoperative ketorolac was associated with reduced opioid usage and postoperative pain.

4. link.springer.com link.springer.com/article/10.1007/s00266-025-05187-y

Perioperative Ketorolac and Hematoma Following Breast ... We analyzed data from six observational studies comprising a total of 3384 patients, of whom 1967 received ketorolac and 1417 did not. Our ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5908486/

Ketorolac May Increase Hematoma Risk in Reduction ... It can be interpreted that it is 2.4 times as likely for a postoperative breast reduction patient who has been exposed to ketorolac to have hematoma formation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10567012/

Ketorolac Safety in Breast Free Flap Surgery The overall incidence of patients who received ketorolac and developed a clinical hematoma was 5.3% compared with 5.3% in the non-ketorolac ...

7. journals.lww.com journals.lww.com/prsgo/fulltext/2025/02000/effectiveness_of_intraoperative_ketorolac_in.48.aspx

Effectiveness of Intraoperative Ketorolac in Outpatient... This study demonstrates that a single dose of intraoperative ketorolac was associated with reduced opioid usage and postoperative pain.