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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03678675
• Other study ID #: Ketorolac Pain Study
• Status: Completed
• Phase: Phase 3
• Start date: May 30, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: June 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Postoperative Change in Hematocrit	The change in patient hematocrit from baseline to POD1	Change in pre-operative hematocrit to POD1 hematocrit
Secondary	Change in Creatinine	The change in patient's creatinine from POD1 to POD2	Change in creatinine from POD1 to POD2
Secondary	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
Secondary	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