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

Information source: Wake Forest School of Medicine
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Acetaminophen (Drug); Placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Wake Forest School of Medicine

Official(s) and/or principal investigator(s):
Peter H Pan, MD, MSEE, Principal Investigator, Affiliation: Wake Forest School of Medicine

Overall contact:
Peter H Pan, MD, MSEE, Phone: 336-718-8278, Email: ppan@wakehealth.edu

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.

Clinical Details

Official title: Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Neuraxial Analgesic Drug consumption per hour

Secondary outcome:

rescue doses

maternal temperature

pain scores

patient satisfaction

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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Peter H Pan, MD, MSEE, Phone: 336-718-8278, Email: ppan@wakehealth.edu

Forsyth Medical Center, Winston-Salem, North Carolina 27103, United States; Recruiting
Peter Pan, MD, MSEE, Phone: 336-718-8278, Email: ppan@wakehealth.edu
Lynnette Harris, BSN, Phone: 336-718-6049, Email: lcharris@wakehealth.edu
Peter H Pan, MD, MSEE, Principal Investigator
Ashley Hambright, MD, Sub-Investigator
Additional Information

Starting date: September 2013
Last updated: July 2, 2014

Page last updated: August 23, 2015

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