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Trial record 47 of 1889 for:    Acetaminophen

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Acetaminophen
Drug: Placebo
Enrollment 33
Recruitment Details Subjects were approached after being admitted to the labor and delivery unit of our facility about participation in this clinical trial
Pre-assignment Details  
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description

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

Acetaminophen: administered every 6 hours by mouth up to 3 doses

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses

Placebo

Period Title: Overall Study
Started 14 19
Completed 12 15
Not Completed 2 4
Arm/Group Title Acetaminophen Placebo Total
Hide Arm/Group Description

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

Acetaminophen: administered every 6 hours by mouth up to 3 doses

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 12 15 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
15
 100.0%
27
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
Female
12
 100.0%
15
 100.0%
27
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 15 participants 27 participants
white
7
  58.3%
11
  73.3%
18
  66.7%
african american
5
  41.7%
2
  13.3%
7
  25.9%
hispanic
0
   0.0%
2
  13.3%
2
   7.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 15 participants 27 participants
12
 100.0%
15
 100.0%
27
 100.0%
1.Primary Outcome
Title Neuraxial Analgesic Drug Consumption Per Hour
Hide Description 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.
Time Frame up to 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description:

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

Acetaminophen: administered every 6 hours by mouth up to 3 doses

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses

Placebo

Overall Number of Participants Analyzed 12 15
Mean (Standard Deviation)
Unit of Measure: milliliters
155.19  (109.56) 143.41  (73.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetaminophen
Comments [Not Specified]
Type of Statistical Test Other
Comments unpaired t-test compared between groups
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method unpaired t-test compared between groups
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments unpaired t-test compared between groups
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method unpaired t-test compared between groups
Comments [Not Specified]
Time Frame information collected up to 24 hours after the initiation of neuraxial analgesia
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Placebo
Hide Arm/Group Description

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

Acetaminophen: administered every 6 hours by mouth up to 3 doses

placebo capsule identical to the acetaminophen capsule will be administered every 6 hours to a maximum of 3 doses

Placebo

All-Cause Mortality
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/15 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter H. Pan, MD, MSEE
Organization: Wake Forest School of Medicine
Phone: 336-718-8278
EMail: ppan@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02181387     History of Changes
Other Study ID Numbers: IRB00023934
First Submitted: March 27, 2014
First Posted: July 3, 2014
Results First Submitted: June 16, 2017
Results First Posted: August 21, 2017
Last Update Posted: September 10, 2018