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

NCT ID: NCT02181387

Last Updated: 2018-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-05

Study Completion Date

2014-06-30

Brief Summary

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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

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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

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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acetaminophen

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

Group Type ACTIVE_COMPARATOR

Acetaminophen

Intervention Type DRUG

administered every 6 hours by mouth up to 4 doses

placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Acetaminophen

administered every 6 hours by mouth up to 4 doses

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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tylenol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter H Pan, MD, MSEE

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00023934

Identifier Type: -

Identifier Source: org_study_id

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