Recruiting

Ketorolac

Sponsor:

Dr. Chandran Medical Prof Corp

Code:

NCT03535116

Conditions

Hematoma Postoperative

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ketorolac

Saline

Study Details

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

Study ID

NCT03535116

Start date

Jan 1, 2020

Status verified date

Sep, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Patients receiving ketorolac

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

placebo comparator: Control

Patients receive saline intravenously towards the end of the operation.

Interventions

Ketorolac

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

Saline

injectable normal saline

Primary outcome measure

  • Hematoma [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

St. Paul's Hospital

Recruiting

Saskatoon, Saskatchewan, Canada, S7M0Z9

Contacts

Geethan Chandran, MD

3063848001

More Information

Sponsor

Dr. Chandran Medical Prof Corp

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Chandran Medical Prof Corp on 2023-09-28.