NCT03678675

Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

Detailed description

This was a single-center, randomized, double-blind, parallel-group trial to assess pain management following cesarean section with increased ketorolac versus placebo. All patients undergoing cesarean section with neuraxial anesthesia received two doses of 30mg IV ketorolac postoperatively per hospital protocol and were then randomized to receive an additional four doses of 30 mg of IV ketorolac or placebo every 6 hours. The primary outcome was the total morphine milligram equivalents (MME) used in the first 72 postoperative hours. Secondary outcomes included the number of patients that used no opioid postoperatively, postoperative pain scores, postoperative change in hematocrit and creatinine, and postoperative satisfaction with inpatient care and pain management. A sample size of 74 per group (n=148) was planned.

Conditions

• Post-operative Pain
• Post-partum Pain
• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Ketorolac	The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.

Timeline

• Start date: 2019-05-30
• Primary completion: 2022-01-31
• Completion: 2022-06-30
• First posted: 2018-09-19
• Last updated: 2022-08-18
• Results posted: 2022-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study