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

Wake Forest University (WFU)

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: Placebo; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02181387

IRB00023934

Details and patient eligibility

About

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.

Full 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

Enrollment: 33 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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33 participants in 2 patient groups, including a placebo group

acetaminophen

Active Comparator group

Description:

1000 mg every 6 hours during labor up to maximum 3 doses

Treatment:

Drug: Acetaminophen

placebo

Placebo Comparator group

Description:

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses

Treatment:

Drug: Placebo