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

Pain Clinical Trial

Official title:

Does Acetaminophen Reduce Neuraxial Analgesic Requirement During Labor

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02181387
• Other study ID #: IRB00023934
• Status: Terminated
• Phase: Phase 4
• Start date: September 5, 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Acetaminophen
administered every 6 hours by mouth up to 4 doses
• Placebo

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuraxial Analgesic Drug Consumption Per Hour	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.	up to 24 hours