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 dosesmaternal 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
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