Trial Outcomes & Findings for RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief (NCT NCT02046382)
NCT ID: NCT02046382
Last Updated: 2018-08-16
Results Overview
Total oxycodone (mg) for breakthrough pain during inpatient stay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
132 participants
Primary outcome timeframe
approximately 2 - 7 days
Results posted on
2018-08-16
Participant Flow
Participant milestones
| Measure |
IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
67
|
|
Overall Study
COMPLETED
|
57
|
47
|
|
Overall Study
NOT COMPLETED
|
8
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief
Baseline characteristics by cohort
| Measure |
IV Acetaminophen
n=57 Participants
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
n=47 Participants
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
29.6 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
29.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
33 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 2 - 7 daysTotal oxycodone (mg) for breakthrough pain during inpatient stay
Outcome measures
| Measure |
IV Acetaminophen
n=57 Participants
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
n=47 Participants
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
|---|---|---|
|
Total Oxycodone (mg)
|
47.0 mg
Standard Deviation 39.1
|
65.0 mg
Standard Deviation 46.2
|
SECONDARY outcome
Timeframe: 2-7 daysOnly outcome for nausea/emesis is reported.
Outcome measures
| Measure |
IV Acetaminophen
n=57 Participants
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
n=47 Participants
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
|---|---|---|
|
Number of Participants With Narcotic Associated Side Effects
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 2-7 daysLength of hospital stay (admission to discharge) will be collected.
Outcome measures
| Measure |
IV Acetaminophen
n=57 Participants
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
n=47 Participants
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
|---|---|---|
|
Length of Stay
|
78 hours
Interval 74.0 to 95.0
|
78 hours
Interval 75.0 to 98.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2-7 daysPatients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.
Outcome measures
| Measure |
IV Acetaminophen
n=57 Participants
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
Normal Saline
n=47 Participants
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
|
|---|---|---|
|
Total Amount of Ibuprofen During Inpatient Stay
|
4786 mg
Standard Deviation 2333
|
5260 mg
Standard Deviation 1915
|
Adverse Events
IV Acetaminophen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place