Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn
Status:
Withdrawn
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been
shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and
obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and
central nervous system depression post operatively, while still providing adequate pain
control for patients. Patients undergoing abdominally based microsurgical breast
reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be
safely discharged from hospital sooner than their counterparts receiving standard of care.
Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical
breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in
addition to standard of care, reduce the length of postoperative hospital stay compared with
an intravenous sham saline regimen?
Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm,
parallel group, superiority, randomized, and double blinded, controlled trial.
Population: The study population includes all females >18 years old post mastectomy
consenting to abdominally based microsurgical breast reconstruction.
Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours
postoperatively for 72 hours. The comparator will be a sham intravenous administration of
normal saline.
Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes
include visual analog scale for pain, breakthrough narcotic consumption, surgical drain
outputs, hematoma, and other complications.
Sample Size: Available data provided estimates for average length of hospital stay and
standard deviation. A minimally clinically significant difference of 1 day was decided on due
to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for
attrition and efficiency losses, a total of 50 patients (25 per group) will be required for
this study.