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

Study Overview
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Brief Summary
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To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.

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.

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

Conditions
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Post-operative Pain, Post-partum Pain, Cesarean Section Complications

Intervention / Treatment
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* Drug: Ketorolac


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Protocol<br>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. | |
| Experimental: Ketorolac Protocol<br>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. | Drug: Ketorolac<br>* The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours | The amount of MME's will be monitored for each group. MME's will be determined by the amount of opiate mediations administered. The MME value can range from 0 to typically 200 MME's, however there is no upper limit of measureable MME's. The MME's for each patient will be a sum of MME's administered throughout the course of the hospitalization. | Within 72 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Pain Score Greater Than 3 | The patient reported pain scores will be recorded and analyzed for each group. The Pain Score is determined by the patient using a visual analog scale with a range from 0-10, where 0 is no pain at all and 10 is the worst pain imaginable for the patient. Pain scores were collected by postpartum nursing staff per institutional policy. The number of patients with a pain score greater than 3 will be reported. A pain score greater than 3 was chosen as a cutoff as this is the pain score at which an opioid may be indicated for analgesia at our institution. | 2 weeks | 
| The Number of Patients That Used no Opioid Postoperatively | The number of patients in each arm that required no opioids for pain control postoperatively. | Within 72 post-operative hours | 
| Postoperative Change in Hematocrit | The change in patient hematocrit from baseline to POD1 | Change in pre-operative hematocrit to POD1 hematocrit | 
| Change in Creatinine | The change in patient's creatinine from POD1 to POD2 | Change in creatinine from POD1 to POD2 | 
| Postoperative Satisfaction With Inpatient Pain Control | Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on postpartum pain management. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients who reported they were very satisfied with their care. | Inpatient pain control satisfaction as reported at two weeks postpartum | 
| Postoperative Satisfaction With Their Inpatient Postpartum Care. | Two weeks after cesarean section, subjects were contacted by telephone to complete a survey on their overall postpartum care. At least three attempts were made to contact subjects by telephone. In the follow-up phone call, patients were asked to rate their satisfaction with their postpartum care: very satisfied, satisfied, neutral, dissatisfied, or very dissatisfied. The number below describes the number of patients that reported they were very satisfied with their care. | Satisfaction with inpatient care as reported at two weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, opiate, cesarean section