Clinical trial NCT03678675: Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Official title: Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-operative Pain
Post-partum Pain
Cesarean Section Complications
Keywords: ketorolac
opiate
cesarean section
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 148
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
timeFrame: Within 72 postoperative hours
Secondary outcomes:
measure: Number of Participants With a Pain Score Greater Than 3
timeFrame: 2 weeks
measure: The Number of Patients That Used no Opioid Postoperatively
timeFrame: Within 72 post-operative hours
measure: Postoperative Change in Hematocrit
timeFrame: Change in pre-operative hematocrit to POD1 hematocrit
measure: Change in Creatinine
timeFrame: Change in creatinine from POD1 to POD2
measure: Postoperative Satisfaction With Inpatient Pain Control
timeFrame: Inpatient pain control satisfaction as reported at two weeks postpartum
measure: Postoperative Satisfaction With Their Inpatient Postpartum Care.
timeFrame: Satisfaction with inpatient care as reported at two weeks postpartum
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References: