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Clinical trial

Use of Perioperative Ketorolac in Breast Surgery to Reduce Post Operative Pain and Opioid Use

ID
Name
19-387
Description
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 arms
Trial start
2020-06-22
Estimated PCD
2023-01-30
Trial end
2023-01-30
Status
Completed
Phase
Early phase I
Treatment
Ketorolac Tromethamine
nonsteroidal anti-inflammatory drug
Arms:
High Dose (30mg) Toradol, Low Dose (15mg) Toradol
Other names:
Toradol
Saline
saline fluid injection
Arms:
Control
Size
183
Primary endpoint
Change of post-operative pain: Likert scale
2 week post operation
Eligibility criteria
Inclusion Criteria: * Patient consents to study * Adult females needing breast reconstruction or breast reduction (day surgeries) Exclusion Criteria: * 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'double blind randomized trial', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 183, 'type': 'ACTUAL'}}
Updated at
2023-02-10

1 organization

1 product

2 indications

Organization
Carilion Clinic
Product
Ketorolac Tromethamine
Indication
Reduction mammoplasty
Indication
Breast Reconstruction