Trial Outcomes & Findings for Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery (NCT NCT02487303)
NCT ID: NCT02487303
Last Updated: 2018-12-05
Results Overview
Cumulative opiate consumption (IV morphine equivalents)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
24 hours
Results posted on
2018-12-05
Participant Flow
Participant milestones
| Measure |
Acetaminophen Intravenous
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
(group 3) no acetaminophen
|
|---|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
48
|
|
Overall Study
COMPLETED
|
47
|
47
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Acetaminophen Intravenous
n=47 Participants
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
n=47 Participants
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
n=47 Participants
(group 3) no acetaminophen
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
28.7 years
n=99 Participants
|
30.5 years
n=107 Participants
|
31.2 years
n=206 Participants
|
30.1 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
57 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=99 Participants
|
47 participants
n=107 Participants
|
47 participants
n=206 Participants
|
141 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 hoursCumulative opiate consumption (IV morphine equivalents)
Outcome measures
| Measure |
Acetaminophen Intravenous
n=47 Participants
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
n=47 Participants
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
n=47 Participants
(group 3) no acetaminophen
|
|---|---|---|---|
|
Cumulative Postoperative Opiate Consumption
|
2.9 mg
Interval 0.0 to 28.0
|
3.8 mg
Interval 0.0 to 17.5
|
5.7 mg
Interval 0.0 to 33.0
|
SECONDARY outcome
Timeframe: 48 hoursTime to first opiate pain medicine requested by patient
Outcome measures
| Measure |
Acetaminophen Intravenous
n=47 Participants
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
n=47 Participants
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
n=47 Participants
(group 3) no acetaminophen
|
|---|---|---|---|
|
Time to First Opiate Rescue
|
25.3 hours
Standard Error 8.5
|
24.0 hours
Standard Error 26.3
|
21.3 hours
Standard Error 23.9
|
SECONDARY outcome
Timeframe: 24 hoursVisual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\]) .
Outcome measures
| Measure |
Acetaminophen Intravenous
n=47 Participants
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
n=47 Participants
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
n=47 Participants
(group 3) no acetaminophen
|
|---|---|---|---|
|
VAS (Visual Analog Scale)
|
37.8 units on a scale
Standard Error 3.23
|
44.3 units on a scale
Standard Error 3.28
|
50.8 units on a scale
Standard Error 3.31
|
SECONDARY outcome
Timeframe: 24 hours postoperativeTime patient meets discharge criteria will be recorded
Outcome measures
| Measure |
Acetaminophen Intravenous
n=47 Participants
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours
|
Acetaminophen Oral
n=47 Participants
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours
|
No Acetaminophen
n=47 Participants
(group 3) no acetaminophen
|
|---|---|---|---|
|
Time Discharge
|
48.4 hours
Standard Deviation 13.7
|
48.6 hours
Standard Deviation 11.3
|
50.5 hours
Standard Deviation 15.7
|
Adverse Events
Acetaminophen Intravenous
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Acetaminophen Oral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Acetaminophen
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