Trial Outcomes & Findings for Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery (NCT NCT02509312)
NCT ID: NCT02509312
Last Updated: 2022-06-07
Results Overview
Estimation of blood loss during surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
Immediately post-op
Results posted on
2022-06-07
Participant Flow
Participant milestones
| Measure |
Ketorolac
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
Intraoperative Checkpoint
|
28
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Ketorolac
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Overall Study
Cesarean after 4pm / Unable to complete enrollment due to floor acuity
|
5
|
3
|
|
Overall Study
Obstetrician refusal
|
0
|
1
|
|
Overall Study
Patient elected for TOLAC
|
1
|
0
|
|
Overall Study
Cesarean deemed stat
|
1
|
0
|
|
Overall Study
Anaphylaxis prior to cord clamp to non-study drug
|
0
|
1
|
Baseline Characteristics
Prospective Effect of Intravenous Ketorolac on Opioid Use, EBL and Complications Following Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Weight (kg)
|
100.0 kg
STANDARD_DEVIATION 24.7 • n=5 Participants
|
93.8 kg
STANDARD_DEVIATION 25.1 • n=7 Participants
|
96.8 kg
STANDARD_DEVIATION 24.9 • n=5 Participants
|
|
BMI (kg/m2)
|
38.1 kg/m^2
STANDARD_DEVIATION 8.5 • n=5 Participants
|
35.1 kg/m^2
STANDARD_DEVIATION 8.2 • n=7 Participants
|
36.5 kg/m^2
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Gravida
|
3 prior pregnancies
n=5 Participants
|
2.5 prior pregnancies
n=7 Participants
|
3 prior pregnancies
n=5 Participants
|
|
Parity
|
1.3 births carried to viability
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.1 births carried to viability
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.2 births carried to viability
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Prior Cesarean delivery (CD)
|
1 prior Cesareans
n=5 Participants
|
1 prior Cesareans
n=7 Participants
|
1 prior Cesareans
n=5 Participants
|
|
Tubal Ligation at time of CD
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Preoperative Hematocrit (Hct)
|
34.6 mg/dl
STANDARD_DEVIATION 3.0 • n=5 Participants
|
34.2 mg/dl
STANDARD_DEVIATION 3.0 • n=7 Participants
|
34.4 mg/dl
STANDARD_DEVIATION 3.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately post-opEstimation of blood loss during surgery
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Estimated Blood Loss (EBL)
|
900 ml
Interval 692.5 to 1047.0
|
800 ml
Interval 600.0 to 1000.0
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumRate of Post-Partum Hemorrhage between groups during the first 24 hours pst-partum.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Post-Partum Hemorrhage
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: POD1Corrected change in Hct on POD1. Performed by subtracting POD1 Hct from POD0 Hct. Correction for transfusion by further subtracting 3 per unit of pRBC transfused to account for the typical change seen per unit transfused.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Corrected Change in Hct on POD1.
|
-5.1 mg/dl
Standard Deviation 3.5
|
-3.5 mg/dl
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumTotal number of uterotonic doses including methylergonovine, carboprost and misoprostol.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Uterotonic Doses
|
0 doses
Interval 0.0 to 0.0
|
0 doses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Intra-op until 24 hours post-partum.Total number of Units of Packed Reb Blood Cell Transfused in intra-op until 24 hours post-partum.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Units of Packed Reb Blood Cell Transfused
|
0 units of pRBCs
Interval 0.0 to 0.0
|
0 units of pRBCs
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumUse of any intravenous hydromorphone administered within the first 24 hours after cesarean delivery.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Hydromorphone Use
Non-use of Opioids
|
17 Participants
|
10 Participants
|
|
Hydromorphone Use
Use of Opioids
|
11 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partum.Total hydromorphone doses in mg in the first 24 hours post-partum.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Total Hydromorphone Dose
|
0 mg
Interval 0.0 to 0.2
|
0.2 mg
Interval 0.0 to 0.4
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumTotal doses of medications to treat pruritus (opioid side-effect) including ondansetron and promethazine.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Anti-emetic Doses
|
0 doses
Interval 0.0 to 1.0
|
0 doses
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumTotal doses of medications to treat pruritus (opioid side-effect) including diphenhydramine, nalbuphine and naloxone.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Pruritus Doses
|
0 doses
Interval 0.0 to 1.0
|
0 doses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumPercentile change in Systolic Blood Pressure at 6,12, and 24 hours for each patient's baseline defined by immediate post-op PACU vitals.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Percentile Change in Systolic Blood Pressure at 6,12, and 24 Hours
6 hours
|
-2.0 Percent change
Standard Deviation 11.6
|
-0.6 Percent change
Standard Deviation 10.00
|
|
Percentile Change in Systolic Blood Pressure at 6,12, and 24 Hours
12 hours
|
-9.10 Percent change
Standard Deviation 8.99
|
-2.85 Percent change
Standard Deviation 10.13
|
|
Percentile Change in Systolic Blood Pressure at 6,12, and 24 Hours
24 hours
|
-5.9 Percent change
Standard Deviation 12.4
|
-3.5 Percent change
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 0 - 24 hours post-partumPercentile change in diastolic Blood Pressure at 6,12, and 24 hours for each patient's baseline defined by immediate post-op PACU vitals.
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Percentile Change in Diastolic Blood Pressure (DBP) at 6,12, and 24 Hours
6 hours
|
12.30 Percent change
Standard Deviation 17.7
|
7.6 Percent change
Standard Deviation 17.6
|
|
Percentile Change in Diastolic Blood Pressure (DBP) at 6,12, and 24 Hours
12 hours
|
8.8 Percent change
Standard Deviation 17.3
|
8.8 Percent change
Standard Deviation 16.2
|
|
Percentile Change in Diastolic Blood Pressure (DBP) at 6,12, and 24 Hours
24 hours
|
12.0 Percent change
Standard Deviation 19.4
|
11.1 Percent change
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: Up to 24 hours post-cesarean deliveryPain score post-Cesarean Delivery using 11-point numerical rating scale (NRS): 0-10 where 0 is no pain and 10 is the worst pain imaginable
Outcome measures
| Measure |
Ketorolac
n=28 Participants
Patients in this arm will be given ketorolac at cord clamp with standard dose of 30 mg, then 3 additional 30 mg doses every 6 hours.
Ketorolac: Patients in experimental arm will receive ketorolac 30 mg in 1 ml at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
Placebo
n=30 Participants
Patients in this arm will be given a placebo medication at cord clamp, and then 3 additional doses of placebo every 6 hours.
Placebo: Patients in the control arm will receive 1 ml of normal saline at time of cord clamp and then for 3 more doses every 6 hours.
Epidural Morphine: All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
Hydromorphone: Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
|
|---|---|---|
|
Change in Pain Score Post-Cesarean Delivery
Baseline
|
0 units on NRS
Interval 0.0 to 0.0
|
0 units on NRS
Interval 0.0 to 0.0
|
|
Change in Pain Score Post-Cesarean Delivery
15 mins
|
0 units on NRS
Interval 0.0 to 0.0
|
0 units on NRS
Interval 0.0 to 0.0
|
|
Change in Pain Score Post-Cesarean Delivery
1 hour
|
0 units on NRS
Interval 0.0 to 3.0
|
0 units on NRS
Interval 0.0 to 6.0
|
|
Change in Pain Score Post-Cesarean Delivery
6 hours
|
1 units on NRS
Interval 0.0 to 4.5
|
3 units on NRS
Interval 1.0 to 6.0
|
|
Change in Pain Score Post-Cesarean Delivery
12 hours
|
2 units on NRS
Interval 0.0 to 4.5
|
3.5 units on NRS
Interval 1.0 to 5.0
|
|
Change in Pain Score Post-Cesarean Delivery
24 hours
|
4.5 units on NRS
Interval 2.5 to 6.5
|
5.5 units on NRS
Interval 3.0 to 7.0
|
Adverse Events
Ketorolac
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John J. Kowalczyk, MD
Beth Israel Deaconess Medical Center
Phone: 617-667-3112
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place