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

NCT02181387 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00023934
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

labor pain; acetaminophen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

acetaminophen

ACTIVE COMPARATOR

1000 mg every 6 hours during labor up to maximum 3 doses

Drug: Acetaminophen

placebo

PLACEBO COMPARATOR

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 4 doses

Drug: Placebo

Interventions

Acetaminophen DRUG

administered every 6 hours by mouth up to 4 doses

Also known as: tylenol

acetaminophen

Placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \>/= 18 years of age not allergic to study medications

You may not qualify if:

• pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Pain; Labor Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Peter H. Pan, MD, MSEE
• Organization: Wake Forest School of Medicine

ppan@wakehealth.edu

336-718-8278

Study Officials

• Peter H Pan, MD, MSEE

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: July 3, 2014
• Study Start: September 5, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 10, 2018
• Results First Posted: August 21, 2017

Record last verified: 2018-08

Locations

US (1)