Back to resultsIncreased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Primary Purpose
Post-operative Pain, Post-partum Pain, Cesarean Section Complications
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring ketorolac, opiate, cesarean section
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.
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Protocol
Ketorolac Protocol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
The Number of Patients That Used no Opioid Postoperatively
The number of patients in each arm that required no opioids for pain control postoperatively.
Postoperative Change in Hematocrit
The change in patient hematocrit from baseline to POD1
Change in Creatinine
The change in patient's 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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03678675
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Post-partum Pain, Cesarean Section Complications
Keywords
ketorolac, opiate, cesarean section
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
The subjects, care providers, and investigators will be blinded to the assignments of groups.
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Protocol
Arm Type
No Intervention
Arm Description
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.
Arm Title
Ketorolac Protocol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
Primary Outcome Measure Information:
Title
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
Description
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.
Time Frame
Within 72 postoperative hours
Secondary Outcome Measure Information:
Title
Number of Participants With a Pain Score Greater Than 3
Description
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.
Time Frame
2 weeks
Title
The Number of Patients That Used no Opioid Postoperatively
Description
The number of patients in each arm that required no opioids for pain control postoperatively.
Time Frame
Within 72 post-operative hours
Title
Postoperative Change in Hematocrit
Description
The change in patient hematocrit from baseline to POD1
Time Frame
Change in pre-operative hematocrit to POD1 hematocrit
Title
Change in Creatinine
Description
The change in patient's creatinine from POD1 to POD2
Time Frame
Change in creatinine from POD1 to POD2
Title
Postoperative Satisfaction With Inpatient Pain Control
Description
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.
Time Frame
Inpatient pain control satisfaction as reported at two weeks postpartum
Title
Postoperative Satisfaction With Their Inpatient Postpartum Care.
Description
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.
Time Frame
Satisfaction with inpatient care as reported at two weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
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