Trial Outcomes & Findings for Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial (NCT NCT03678675)
NCT ID: NCT03678675
Last Updated: 2022-08-18
Results Overview
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.
COMPLETED
PHASE3
148 participants
Within 72 postoperative hours
2022-08-18
Participant Flow
Participant milestones
| Measure |
Standard Protocol
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.
|
Ketorolac Protocol
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.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Increased Ketorolac Administration After Cesarean Section and Its Effect on Opioid Use: a Randomized Control Trial
Baseline characteristics by cohort
| Measure |
Standard Protocol
n=74 Participants
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.
|
Ketorolac Protocol
n=74 Participants
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.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5 • n=99 Participants
|
32.6 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
32.5 years
STANDARD_DEVIATION 5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
15 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
32 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not reported
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=99 Participants
|
74 participants
n=107 Participants
|
148 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Within 72 postoperative hoursThe 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.
Outcome measures
| Measure |
Standard Protocol
n=74 Participants
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.
|
Ketorolac Protocol
n=74 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
The Total Morphine Milligram Equivalents (MME) Used in the First 72 Postoperative Hours
|
60.0 MME
Interval 30.0 to 112.5
|
30 MME
Interval 0.0 to 67.5
|
SECONDARY outcome
Timeframe: 2 weeksThe 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.
Outcome measures
| Measure |
Standard Protocol
n=74 Participants
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.
|
Ketorolac Protocol
n=74 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Number of Participants With a Pain Score Greater Than 3
|
40 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Within 72 post-operative hoursThe number of patients in each arm that required no opioids for pain control postoperatively.
Outcome measures
| Measure |
Standard Protocol
n=74 Participants
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.
|
Ketorolac Protocol
n=74 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
The Number of Patients That Used no Opioid Postoperatively
|
24 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Change in pre-operative hematocrit to POD1 hematocritPopulation: Post-operative day 1 hematocrit was available on 72 patients in the standard group and 73 patients in the ketorolac group.
The change in patient hematocrit from baseline to POD1
Outcome measures
| Measure |
Standard Protocol
n=72 Participants
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.
|
Ketorolac Protocol
n=73 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Postoperative Change in Hematocrit
|
-5.5 percentage of red blood cells in blood
Standard Deviation 3.5
|
-5.5 percentage of red blood cells in blood
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Change in creatinine from POD1 to POD2Population: Post operative day 1 and 2 creatinine was collected on 68 patients in the standard group and 65 patients in the ketorolac group.
The change in patient's creatinine from POD1 to POD2
Outcome measures
| Measure |
Standard Protocol
n=68 Participants
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.
|
Ketorolac Protocol
n=65 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Change in Creatinine
|
.03 mg/dL
Standard Deviation .05
|
.59 mg/dL
Standard Deviation .01
|
SECONDARY outcome
Timeframe: Inpatient pain control satisfaction as reported at two weeks postpartumPopulation: 52 patients in the standard protocol and 52 patients in the ketorolac group responded to the 2 week postpartum survey.
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.
Outcome measures
| Measure |
Standard Protocol
n=52 Participants
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.
|
Ketorolac Protocol
n=52 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Postoperative Satisfaction With Inpatient Pain Control
|
35 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Satisfaction with inpatient care as reported at two weeks postpartumPopulation: 52 patients in the standard protocol and 52 patients in the ketorolac group responded to the 2 week postpartum survey.
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.
Outcome measures
| Measure |
Standard Protocol
n=52 Participants
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.
|
Ketorolac Protocol
n=52 Participants
Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 5 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Postoperative Satisfaction With Their Inpatient Postpartum Care.
|
39 Participants
|
39 Participants
|
Adverse Events
Standard Protocol
Ketorolac Protocol
Serious adverse events
| Measure |
Standard Protocol
n=74 participants at risk
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.
|
Ketorolac Protocol
n=74 participants at risk
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.
Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
|
|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/74 • Up to 6 weeks postpartum
|
1.4%
1/74 • Number of events 1 • Up to 6 weeks postpartum
|
|
Pregnancy, puerperium and perinatal conditions
Endometritis
|
1.4%
1/74 • Number of events 1 • Up to 6 weeks postpartum
|
0.00%
0/74 • Up to 6 weeks postpartum
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place