Phase 3
Completed N=148
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Post-operative Pain · Post-partum Pain · Cesarean Section Complications
Source: ClinicalTrials.gov NCT03678675 ↗
Enrolled (actual)
148
Serious AEs
1.4%
Results posted
Aug 2022
Primary outcomePrimary: The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours — 60.0; 30 MME
◆ Published Evidence
Emerging
4citations · ~1 / year
Increased Scheduled Intravenous Ketorolac After Cesarean Delivery and Its Effect on Opioid Use: A Randomized Controlled Trial.
Summary
To evaluate the efficacy of increased ketorolac in reducing opioid use after cesarean section.
Linked Publications
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Increased Scheduled Intravenous Ketorolac After Cesarean Delivery and Its Effect on Opioid Use: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours |
60.0; 30 | — |
| SECONDARY Number of Participants With a Pain Score Greater Than 3 |
40; 19 | — |
| SECONDARY The Number of Patients That Used no Opioid Postoperatively |
24; 9 | — |
| SECONDARY Postoperative Change in Hematocrit |
-5.5; -5.5 | — |
| SECONDARY Change in Creatinine |
.03; .59 | — |
| SECONDARY Postoperative Satisfaction With Inpatient Pain Control |
35; 29 | — |
| SECONDARY Postoperative Satisfaction With Their Inpatient Postpartum Care. |
39; 39 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03678675) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.