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

NCT03535116 | Unknown Phase 4

• 1 other identifier: 33
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Hematoma Postoperative

Outcome Measures

Primary Outcomes (1)

• Hematoma

  Postoperative hematoma

  6 weeks

Study Arms (2)

Patients receiving ketorolac

EXPERIMENTAL

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

Drug: Ketorolac

Control

PLACEBO COMPARATOR

Patients receive saline intravenously towards the end of the operation.

Drug: Saline

Interventions

Ketorolac DRUG

Toradol is a type of brand name. We will be using the generic version.

Patients receiving ketorolac

Saline DRUG

injectable normal saline

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: must be female as these are surgeries for breast reductions
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• female
• clinically met criteria for breast reduction(large heavy breasts)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Chandran Medical Prof Corp: lead

Study Sites (1)

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M0Z9, Canada

RECRUITING

MeSH Terms

Interventions

Ketorolac; Sodium Chloride

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Geethan Chandran, MD

CONTACT

(306)380-3910; drgeethanchandran@gmail.com

Stephanie Chandran, RN

CONTACT

(306)380-0870; stephchandran@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: drug vs placebo(saline). Identification is in a sealed envelope. The anesthetist gives the medication without telling the surgeon or the patient what medication is given(patient will be under a general anesthetic). Neither patient or surgeon will know what the patient gets until the follow up period(6 weeks) is completed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Double Blind Randomized Control Trial of breast reduction patients and their postoperative hematoma rates with the use of ketorolac

Study Record Dates

• First Submitted: May 13, 2018
• First Posted: May 24, 2018
• Study Start: January 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)