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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-30

Study Completion Date

2022-06-30

Brief Summary

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

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Detailed Description

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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

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Post-operative Pain Post-partum Pain Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

The subjects, care providers, and investigators will be blinded to the assignments of groups.

Study Groups

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Standard Protocol

Subjects randomized to the standard group will receive the standard postoperative pain protocol that is currently used at Tufts Medical Center. It includes two doses of IV Ketorolac every 6 hours as needed for postoperative pain. Ibuprofen would be ordered 6 hours following the last dose after the last study drug.

Group Type NO_INTERVENTION

No interventions assigned to this group

Ketorolac Protocol

Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit.

Group Type EXPERIMENTAL

Ketorolac

Intervention Type DRUG

The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.

Interventions

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Ketorolac

The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
* The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
* The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.

Exclusion Criteria

* Patients with allergy to ketorolac, NSAIDS or aspirin
* Patients with peptic ulcer disease, preexisting kidney or liver disease.
* Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
* Patient is hemodynamically unstable due to hemorrhage.
* Patient requires therapeutic anticoagulation in the post-operative period
* Patients with peripartum cardiomyopathy
* Provider decision to exclude patient.
* Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
* A study subject may participate in another research study while participating in this research study.

Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes