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Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT02487303
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Pain, Postoperative
Interventions Drug: Acetaminophen Intravenous
Drug: Acetaminophen Oral
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours

(group 3) no acetaminophen
Period Title: Overall Study
Started 49 51 48
Completed 47 47 47
Not Completed 2 4 1
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen Total
Hide Arm/Group Description

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours

(group 3) no acetaminophen Total of all reporting groups
Overall Number of Baseline Participants 47 47 47 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 47 participants 141 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
 100.0%
47
 100.0%
47
 100.0%
141
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 47 participants 47 participants 47 participants 141 participants
28.7
(19 to 44)
30.5
(21 to 43)
31.2
(18 to 49)
30.1
(18 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 47 participants 141 participants
Female
47
 100.0%
47
 100.0%
47
 100.0%
141
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 47 participants 141 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.1%
0
   0.0%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
22
  46.8%
14
  29.8%
21
  44.7%
57
  40.4%
White
24
  51.1%
32
  68.1%
26
  55.3%
82
  58.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   2.1%
0
   0.0%
1
   0.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 47 participants 47 participants 141 participants
47 47 47 141
1.Primary Outcome
Title Cumulative Postoperative Opiate Consumption
Hide Description Cumulative opiate consumption (IV morphine equivalents)
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description:

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours

(group 3) no acetaminophen
Overall Number of Participants Analyzed 47 47 47
Mean (Full Range)
Unit of Measure: mg
2.9
(0 to 28)
3.8
(0 to 17.5)
5.7
(0 to 33)
2.Secondary Outcome
Title Time to First Opiate Rescue
Hide Description Time to first opiate pain medicine requested by patient
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description:
1 gram IV acetaminophen every 8 hours for three doses
1 gram oral acetaminophen every 8 hours for three doses
No acetaminophen
Overall Number of Participants Analyzed 47 47 47
Mean (Standard Error)
Unit of Measure: hours
25.3  (8.5) 24.0  (26.3) 21.3  (23.9)
3.Secondary Outcome
Title VAS (Visual Analog Scale)
Hide Description Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between “no pain” and “worst pain.” For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it could be” or “worst imaginable pain” (score of 100 [100‐mm scale]) .
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description:
1 gram IV acetaminophen every 8 hours for three doses
1 gram oral acetaminophen every 8 hours for three doses
No acetaminophen
Overall Number of Participants Analyzed 47 47 47
Mean (Standard Error)
Unit of Measure: units on a scale
37.8  (3.23) 44.3  (3.28) 50.8  (3.31)
4.Secondary Outcome
Title Time Discharge
Hide Description Time patient meets discharge criteria will be recorded
Time Frame 24 hours postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description:

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours

(group 3) no acetaminophen
Overall Number of Participants Analyzed 47 47 47
Mean (Standard Deviation)
Unit of Measure: hours
48.4  (13.7) 48.6  (11.3) 50.5  (15.7)
Time Frame The timeframe for adverse event data was collected up to 48 hours.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Hide Arm/Group Description

(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours

(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours

(group 3) no acetaminophen
All-Cause Mortality
Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acetaminophen Intravenous Acetaminophen Oral No Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (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 Intravenous Acetaminophen Oral No Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/47 (0.00%)   0/47 (0.00%)   0/47 (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: Sylvia Wilson
Organization: Medical University of South Carolina
Phone: 8437921414
EMail: wilsosh@musc.edu
Publications of Results:
Layout table for additonal information
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02487303     History of Changes
Other Study ID Numbers: Pro00041193
First Submitted: June 25, 2015
First Posted: July 1, 2015
Results First Submitted: July 30, 2018
Results First Posted: December 5, 2018
Last Update Posted: December 5, 2018