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

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

It has been a longstanding teaching in plastic surgery that intra-operative ketorolac use for postoperative pain control increases hematoma and bleeding in breast reduction surgery. However, there is no literature that supports this teaching. Ketorolac is used routinely in free flap reconstruction including breast reconstruction as well as many other surgeries including hand surgery without increased risks of hematoma or bleeding. 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/bleeding in breast reduction. If there is no increased risk of hematoma, then ketorolac can be used safely for postoperative pain control with an increased risk of hematoma/bleeding. Normally, without using ketorolac, the hematoma rates in a breast reduction are 1-2%.

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+