Investigating the impact of ketorolac on hematoma rates in breast reduction surgery
The Effect of Intra-operative Ketorolac on Hematoma Rates in Breast Reduction Surgery: A Double Blind Randomized Control Trial
This study is testing if giving ketorolac during breast reduction surgery helps reduce bleeding and bruising compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dr. Chandran Medical Prof Corp Academic / other |
| Locations | 1 site (Saskatoon, Saskatchewan) |
| Trial ID | NCT03535116 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether the use of intra-operative ketorolac affects the rates of hematoma and bleeding in patients undergoing breast reduction surgery. It is a double-blind randomized control trial comparing ketorolac to a placebo, with a sample size of 520 patients. The hypothesis is that there will be no significant difference in hematoma rates between the two groups, allowing for the safe use of ketorolac for postoperative pain management. The study will recruit patients during their initial consultations for breast reduction, ensuring they meet specific clinical criteria.
Who should consider this trial
Good fit: Ideal candidates are females over 18 years old who clinically qualify for breast reduction due to large, heavy breasts.
Not a fit: Patients who are smokers, morbidly obese, have a history of kidney failure, or are allergic to non-steroidal anti-inflammatories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow for safer postoperative pain management in breast reduction surgeries without increasing the risk of hematoma.
How similar studies have performed: While the teaching suggests increased hematoma risk with ketorolac, there is limited literature supporting this, making this study's approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age \> 18 * female * clinically met criteria for breast reduction(large heavy breasts) Exclusion Criteria: * smokers * morbid obesity * history of kidney failure * allergy to non steroidal anti-inflammatories * did not wish or unable to consent to be in the study
Where this trial is running
Saskatoon, Saskatchewan
- St. Paul's Hospital — Saskatoon, Saskatchewan, Canada (Recruiting)
Study contacts
- Study coordinator: Geethan Chandran, MD
- Email: drgeethanchandran@gmail.com
- Phone: (306)380-3910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.