Trial Outcomes & Findings for Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING) (NCT NCT05248984)
NCT ID: NCT05248984
Last Updated: 2026-02-25
Results Overview
Comparing the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
COMPLETED
PHASE4
92 participants
After cesarean surgery up to 24 hours.
2026-02-25
Participant Flow
Participant milestones
| Measure |
Ketorolac 30 mg
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING)
Baseline characteristics by cohort
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=24 Participants
|
46 Participants
n=20 Participants
|
92 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
32.2 Years
STANDARD_DEVIATION 0 • n=24 Participants
|
32.2 Years
STANDARD_DEVIATION 0 • n=20 Participants
|
32.2 Years
STANDARD_DEVIATION 0 • n=40 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=24 Participants
|
46 Participants
n=20 Participants
|
92 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=24 Participants
|
3 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=24 Participants
|
43 Participants
n=20 Participants
|
85 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=24 Participants
|
13 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=24 Participants
|
31 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=24 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=24 Participants
|
46 participants
n=20 Participants
|
92 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: After cesarean surgery up to 24 hours.Comparing the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Comparing the Morphine Milligram Equivalents (MME) Use in the First 24 Hours. Postoperatively After Cesarean Section
|
7.5 Morphine milligram equivalents
Interval 0.0 to 22.5
|
7.5 Morphine milligram equivalents
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: After cesarean surgery during hospital stay up to 2-3 days.Comparing the morphine milligram equivalents (MME) use during hospital stay postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Comparing the Morphine Milligram Equivalents (MME) Use During Hospital Stay.
|
30 Morphine milligram equivalents
Interval 7.5 to 54.5
|
15 Morphine milligram equivalents
Interval 0.0 to 37.5
|
SECONDARY outcome
Timeframe: After cesarean surgery up to 24 hours.Comparing patient reported pain score assessment on a scale of 0-10 in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain 1. Hardly notice pain 2. Notice pain does not interfere with activities 3. Sometimes distracts me 4. Distracts me, can do usual activities 5. Interrupts some activities 6. Hard to ignore, avoid usual activities 7. Focus of attention, prevents doing daily activities 8. Awful, hard to do anything 9. Can't bear the pain, unable to do anything 10. As bas as it could be nothing else matters
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Comparing Patient Reported Pain Score Assessment.
|
6 Scores on a scale
Interval 5.0 to 7.0
|
6 Scores on a scale
Interval 5.0 to 7.0
|
SECONDARY outcome
Timeframe: After cesarean surgery up to 2-3 days.Comparing the time to first administration of opioid pain medication postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Comparing the Time to First Administration of Opioid Pain Medication Postoperatively.
|
2.75 Hours
Interval 2.0 to 5.0
|
15 Hours
Interval 3.0 to 25.0
|
SECONDARY outcome
Timeframe: After cesarean surgery during hospital stay up to 2-3 days.Comparing the pain score on discharge home in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery. Pain scores postpartum from 0 to 10 based on the Defense and Veterans Pain Rating Scale (DVPRS). 0- No pain 1. Hardly notice pain 2. Notice pain does not interfere with activities 3. Sometimes distracts me 4. Distracts me, can do usual activities 5. Interrupts some activities 6. Hard to ignore, avoid usual activities 7. Focus of attention, prevents doing daily activities 8. Awful, hard to do anything 9. Can't bear the pain, unable to do anything 10. As bas as it could be nothing else matters
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Pain Score on Discharge Home
|
2 Scores on a scale
Interval 0.0 to 4.0
|
2 Scores on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: After cesarean surgery during hospital stay up to 2-3 days.Evaluating adverse maternal outcomes (acute kidney injury, admission to intensive care unit, maternal death).
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Number of Participants With Adverse Maternal Outcomes.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: After cesarean surgery during hospital stay up to 2-3 days.Evaluating type of skin incision (Pfannenstiel vs. Vertical Midline).
Outcome measures
| Measure |
Ketorolac 30 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 30mg
Ketorolac 30 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 30mg
|
Ketorolac 60 mg
n=46 Participants
Participants will be assigned of single dose of intravenous (IV) Ketorolac 60mg
Ketorolac 60 Mg: Participants will receive single dose of intravenous (IV) Ketorolac 60mg
|
|---|---|---|
|
Evaluating Type of Skin Incision.
Supraumbilical midline
|
1 Participants
|
1 Participants
|
|
Evaluating Type of Skin Incision.
Pfannenstiel
|
45 Participants
|
45 Participants
|
Adverse Events
Ketorolac 30 mg
Ketorolac 60 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place