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

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ClinicalTrials.gov Identifier: NCT02181387
Recruitment Status : Terminated (funding and compounding issues)
First Posted : July 3, 2014
Results First Posted : August 21, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Drug: Acetaminophen Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor
Actual Study Start Date : September 5, 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: acetaminophen
1000 mg every 6 hours during labor up to maximum 3 doses
 Drug: Acetaminophen
administered every 6 hours by mouth up to 4 doses
Other Name: tylenol
Placebo Comparator: placebo
placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Neuraxial Analgesic Drug Consumption Per Hour [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02181387


Locations
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United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Peter H Pan, MD, MSEE Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02181387    
Other Study ID Numbers: IRB00023934
First Posted: July 3, 2014    Key Record Dates
Results First Posted: August 21, 2017
Last Update Posted: September 10, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
labor pain
acetaminophen
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics