NCT04439396

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 183 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The investigators will perform a double blinded, prospective randomized trial of perioperative ketorolac (Toradol) on breast reduction and breast reconstruction procedures. Patients will be randomized into three groups: group 1 will receive a perioperative dose of ketorolac (Toradol, 15mg), group 2 will receive ketorolac (Toradol, 30mg), and group 3 will be the control and receive a placebo of saline. Patients will be asked to complete a diary or log of their average pain and pain medication use to be turned in at a 2 week follow up visit. The patients, surgeons, anesthesiologist will not know whether the patient received ketorolac (Toradol) intraoperatively. Patients' pain will be assessed using pain scores in the immediate post-operative period, on post-operative day 1, and at their two-week follow up appointment. If patients leave the same day then they will only have two pain score assessments; on day of surgery and at their two-week follow up. Additionally, patients will be asked to assess their average pain (scale of 1-10 with 1 being no pain and 10 being extreme pain) in morning and evenings using a patient diary for the two week post-op period. The patient's opioid use will be measured by their opioid use during their hospital stay, as well as how many prescription narcotic pills the patient used to manage their pain at home, as documented using the patient diary.

Conditions

• Breast Reduction
• Breast Reconstruction

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	nonsteroidal anti-inflammatory drug
OTHER	Saline	saline fluid injection

Timeline

• Start date: 2020-06-22
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2020-06-19
• Last updated: 2023-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study