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

Phase 4

Terminated

• Conditions: Pain
• Interventions: Drug: Placebo; Drug: Acetaminophen

• Registration Number: NCT02181387
• Lead Sponsor: Wake Forest University Health Sciences

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

Study Timeline

• Study Start: 2013-09-05
• Study First Submitted: 2014-03-27
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-03
• Results First Submitted: 2017-06-16
• Results First Submitted QC: 2017-07-20
• Results First Posted: 2017-08-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses
acetaminophen	Acetaminophen	1000 mg every 6 hours during labor up to maximum 3 doses

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States