Trial Outcomes & Findings for IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women (NCT NCT02267772)
NCT ID: NCT02267772
Last Updated: 2021-01-22
Results Overview
The visual analogue scale (VAS) ranges from 0mm to 140mm. The subject will be asked to mark with a pen on the scale to rate their pain. Negative differences in scores indicated a pain score worse than baseline and positive differences indicated an improved pain score from baseline.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
baseline, 120 minutes after administration
Results posted on
2021-01-22
Participant Flow
163 were enrolled, including those in Group 1 (Pregnant women with uterine contractions, but not in labor), Group 2 (Pregnant women with uterine contractions in the first stage of labor), and Group 3 (Pregnant women with a medical condition associated with pain). The participant flow only reflects participants enrolled in Group 1 and Group 2, and not those in Group 3.
Participant milestones
| Measure |
IV Acetaminophen
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
Randomized
|
50
|
52
|
|
Overall Study
Received Study Drug
|
48
|
52
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IV Acetaminophen vs IV Morphine for Pain Control in Pregnant Women
Baseline characteristics by cohort
| Measure |
IV Acetaminophen
n=48 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=52 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
27.5 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
27.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 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
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
52 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 120 minutes after administrationPopulation: For the IV Acetaminophen arm, data were collected for 24 out of 30 participants in pre-labor and 18 out of 18 participants in the 1st stage of labor. For the IV morphine arm, data were collected for 30 out of 32 participants in pre-labor and 20 out of 20 participants in the 1st stage of labor.
The visual analogue scale (VAS) ranges from 0mm to 140mm. The subject will be asked to mark with a pen on the scale to rate their pain. Negative differences in scores indicated a pain score worse than baseline and positive differences indicated an improved pain score from baseline.
Outcome measures
| Measure |
IV Acetaminophen
n=42 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=50 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
pre-labor group
|
2.67 score on a scale
Standard Deviation 3.8
|
3.2 score on a scale
Standard Deviation 5.1
|
|
Change in Pain Intensity as Assessed by a Visual Analogue Scale (VAS)
first stage of labor group
|
-18.2 score on a scale
Standard Deviation 13.2
|
-4.8 score on a scale
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: 24 hrsPopulation: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours after administrationOutcome measures
| Measure |
IV Acetaminophen
n=50 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=52 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Number of Participants Who Received Rescue Medications
|
30 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 24 hours after administrationPopulation: Data were not collected for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hours after administrationPopulation: For the IV Acetaminophen arm, data were collected for 30 out of 30 participants in pre-labor and 18 out of 18 participants in the 1st stage of labor. For the IV morphine arm, data were collected for 32 out of 32 participants in pre-labor and 20 out of 20 participants in the 1st stage of labor.
Outcome measures
| Measure |
IV Acetaminophen
n=48 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=52 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Total Amount of Study Drug Administered
pre-labor group
|
1600 milligrams
Standard Deviation 952.2
|
6.4 milligrams
Standard Deviation 1.9
|
|
Total Amount of Study Drug Administered
1st stage of labor group
|
1055 milligrams
Standard Deviation 229
|
2.3 milligrams
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: 24hrsPopulation: Data were not collected for this outcome measure.
This will be patient reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 hour after administrationPopulation: Data for this outcome measure were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm.
Maternal side effects include nausea, vomiting, headache, pruritus, insomnia, and drowsiness.
Outcome measures
| Measure |
IV Acetaminophen
n=43 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=51 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Number of Participants With Maternal Side Effects
nausea
|
2 Participants
|
2 Participants
|
|
Number of Participants With Maternal Side Effects
vomiting
|
0 Participants
|
3 Participants
|
|
Number of Participants With Maternal Side Effects
headache
|
5 Participants
|
6 Participants
|
|
Number of Participants With Maternal Side Effects
pruritus
|
2 Participants
|
4 Participants
|
|
Number of Participants With Maternal Side Effects
insomnia
|
5 Participants
|
7 Participants
|
|
Number of Participants With Maternal Side Effects
drowsiness
|
17 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 1 hour after administrationPopulation: Data for this outcome measure were not collected for 6 in the IV Acetaminophen arm and 4 in the IV morphine arm.
Changes in fetal heart rate tracing include acceleration, decelerations, and variability.
Outcome measures
| Measure |
IV Acetaminophen
n=42 Participants
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=48 Participants
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
Number of Participants With Fetal Heart Rate Changes
absence of accelerations
|
4 Participants
|
12 Participants
|
|
Number of Participants With Fetal Heart Rate Changes
late decelerations
|
1 Participants
|
1 Participants
|
|
Number of Participants With Fetal Heart Rate Changes
minimal or absent variability
|
4 Participants
|
3 Participants
|
Adverse Events
IV Acetaminophen
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
IV Morphine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IV Acetaminophen
n=43 participants at risk；n=48 participants at risk
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=51 participants at risk；n=52 participants at risk
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
General disorders
Adverse reaction to demerol administered as rescue medication, which required narcan for reversal
|
2.1%
1/48 • Number of events 1 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
0.00%
0/52 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
Other adverse events
| Measure |
IV Acetaminophen
n=43 participants at risk；n=48 participants at risk
IV acetaminophen for pain control
IV Acetaminophen: IV Acetaminophen
|
IV Morphine
n=51 participants at risk；n=52 participants at risk
IV morphine for pain control
IV Morphine: IV Morphine
|
|---|---|---|
|
General disorders
Nausea
|
4.7%
2/43 • Number of events 2 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
3.9%
2/51 • Number of events 2 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/43 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
5.9%
3/51 • Number of events 3 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
|
General disorders
Headache
|
11.6%
5/43 • Number of events 5 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
11.8%
6/51 • Number of events 6 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
2/43 • Number of events 2 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
7.8%
4/51 • Number of events 4 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
|
General disorders
Insomnia
|
11.6%
5/43 • Number of events 5 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
13.7%
7/51 • Number of events 7 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
|
General disorders
Drowsiness
|
39.5%
17/43 • Number of events 17 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
29.4%
15/51 • Number of events 15 • 1 hour after administration
Other (Not Including Serious) Adverse Events were not collected for 5 in the IV Acetaminophen arm and 1 in the IV morphine arm. All participants who study drug were assessed for serious adverse events (SAEs) and Mortality.
|
Additional Information
Jerrie S. Refuerzo, MD, Associate Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-6416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place