Pain
Conditions
Keywords
labor pain, acetaminophen
Brief summary
The hypothesis is if administration of acetaminophen during labor will reduce the amount of neuraxial pain medication required for comfort. For the study, Acetaminophen or placebo capsules will be administered at the time of neuraxial analgesia placement and then administered every 6 hours until delivery. Overall consumption of neuraxial pain medication will be determined.
Detailed description
Acetaminophen 1000 mg or placebo capsules will be administered at the time of neuraxial analgesia placement and continued every 6 hours until delivery. Vital signs, scores for pain, nausea, itching, and sleepiness will be also obtained. Evaluation of consumption of neuraxial analgesic medication will be included in the final analysis for the differences between the 2 groups
Interventions
DRUGAcetaminophen
administered every 6 hours by mouth up to 4 doses
DRUGPlacebo
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* \>/= 18 years of age not allergic to study medications
Exclusion criteria
* pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuraxial Analgesic Drug Consumption Per Hour | up to 24 hours | subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery. |
Countries
United States
Participant flow
Recruitment details
Subjects were approached after being admitted to the labor and delivery unit of our facility about participation in this clinical trial
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen 1000 mg every 6 hours during labor up to maximum 3 doses
Acetaminophen: administered every 6 hours by mouth up to 3 doses | 12 |
| Placebo placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses
Placebo | 15 |
| Total | 27 |
Baseline characteristics
| Characteristic | Acetaminophen | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 15 Participants | 27 Participants |
| Race/Ethnicity, Customized african american | 5 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized hispanic | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized white | 7 Participants | 11 Participants | 18 Participants |
| Region of Enrollment United States | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 15 |
| other Total, other adverse events | 0 / 12 | 0 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 15 |
Outcome results
Primary
Neuraxial Analgesic Drug Consumption Per Hour
subject evaluated every 2 hours with the amount of neuraxial analgesia consumed during that time period. Study med administered up to 24 hours. labor analgesia continue until delivery.
Time frame: up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen | Neuraxial Analgesic Drug Consumption Per Hour | 155.19 milliliters | Standard Deviation 109.56 |
| Placebo | Neuraxial Analgesic Drug Consumption Per Hour | 143.41 milliliters | Standard Deviation 73.48 |
p-value: >0.05unpaired t-test compared between groups
p-value: >0.05unpaired t-test compared between groups