Toradol (Ketorolac) in Breast Surgery to Reduce Pain & Opioid Use
Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use
1 other identifier
interventional
183
1 country
1
Brief Summary
The purpose of this study is to investigate whether perioperative single-dose administration of ketorolac (Toradol) can reduce post-operative pain after breast surgery, thereby decreasing post-operative opioid use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 19, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2023
CompletedFebruary 10, 2023
February 1, 2023
2.6 years
June 17, 2020
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change of post-operative pain: Likert scale
This will be assessed by using a Likert scale(0=no pain to 10=extreme pain) for pain in the post-operative period before they are discharged. If patients are kept overnight then another pain assessment will be done. Additionally, patients will keep a 2-week diary of average pain in the morning and evening each day until their 2 week follow up visit.
2 week post operation
Secondary Outcomes (2)
Change of narcotic use
2 weeks post operation
Complication assessment
2 weeks to 90 days post operation
Study Arms (3)
Control
PLACEBO COMPARATORSaline injection administered during surgical procedure
Low Dose (15mg) Toradol
EXPERIMENTAL15mg ketorolac (toradol) administered during surgery
High Dose (30mg) Toradol
EXPERIMENTAL30mg ketorolac (toradol) administered during surgery
Interventions
nonsteroidal anti-inflammatory drug
Eligibility Criteria
You may qualify if:
- Patient consents to study
- Adult females needing breast reconstruction or breast reduction (day surgeries)
You may not qualify if:
- Patients with known kidney disease
- Patient does not consent
- patients with history of bleeding disorder, peptic ulcer disease, renal disease, blood thinners use, bariatric surgery and any other contraindications of Toradol use
- patients currently taking aspirin
- pregnant women (not standard to operate on this population anyway)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Carilion Cliniclead
Study Sites (1)
James T. Thompson
Roanoke, Virginia, 24016, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Thompson
Carilion Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- double blind randomized trial
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Plastic and Reconstructive Surgeon
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 19, 2020
Study Start
June 22, 2020
Primary Completion
January 30, 2023
Study Completion
January 30, 2023
Last Updated
February 10, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share