Trial Outcomes & Findings for Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? (NCT NCT02181387)

Last Updated: 2018-09-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

33 participants

Primary outcome timeframe

up to 24 hours

Results posted on

2018-09-10

Participant Flow

Subjects were approached after being admitted to the labor and delivery unit of our facility about participation in this clinical trial

Participant milestones

Participant milestones
Measure	Acetaminophen 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses	Placebo placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo
Overall Study STARTED	14	19
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acetaminophen n=12 Participants 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses	Placebo n=15 Participants placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo	Total n=27 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized white	7 Participants n=93 Participants	11 Participants n=4 Participants	18 Participants n=27 Participants
Race/Ethnicity, Customized african american	5 Participants n=93 Participants	2 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized hispanic	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	12 Participants n=93 Participants	15 Participants n=4 Participants	27 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Acetaminophen n=12 Participants 1000 mg every 6 hours during labor up to maximum 3 doses Acetaminophen: administered every 6 hours by mouth up to 3 doses	Placebo n=15 Participants placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses Placebo
Neuraxial Analgesic Drug Consumption Per Hour	155.19 milliliters Standard Deviation 109.56	143.41 milliliters Standard Deviation 73.48

Adverse Events

Acetaminophen

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

Peter H. Pan, MD, MSEE

Wake Forest School of Medicine

Phone: 336-718-8278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place