Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 of 1876 for:    Acetaminophen

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Cesarean Pain Relief

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046382
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : January 23, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Supportive Care
Conditions Cesarean Section
Pain, Postoperative
Interventions Drug: IV Acetaminophen
Drug: Placebo
Enrollment 132
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Period Title: Overall Study
Started 65 67
Completed 57 47
Not Completed 8 20
Arm/Group Title IV Acetaminophen Normal Saline Total
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Total of all reporting groups
Overall Number of Baseline Participants 57 47 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 47 participants 104 participants
29.6  (6.0) 29.6  (6.1) 29.6  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 47 participants 104 participants
Female
57
 100.0%
47
 100.0%
104
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 57 participants 47 participants 104 participants
White
33
  57.9%
27
  57.4%
60
  57.7%
African American
21
  36.8%
19
  40.4%
40
  38.5%
Multiracial
2
   3.5%
1
   2.1%
3
   2.9%
Other
1
   1.8%
0
   0.0%
1
   1.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 57 participants 47 participants 104 participants
57
 100.0%
47
 100.0%
104
 100.0%
1.Primary Outcome
Title Total Oxycodone (mg)
Hide Description Total oxycodone (mg) for breakthrough pain during inpatient stay
Time Frame approximately 2 - 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Overall Number of Participants Analyzed 57 47
Mean (Standard Deviation)
Unit of Measure: mg
47.0  (39.1) 65.0  (46.2)
2.Secondary Outcome
Title Number of Participants With Narcotic Associated Side Effects
Hide Description Only outcome for nausea/emesis is reported.
Time Frame 2-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Overall Number of Participants Analyzed 57 47
Measure Type: Count of Participants
Unit of Measure: Participants
17
  29.8%
9
  19.1%
3.Secondary Outcome
Title Length of Stay
Hide Description Length of hospital stay (admission to discharge) will be collected.
Time Frame 2-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Overall Number of Participants Analyzed 57 47
Median (Inter-Quartile Range)
Unit of Measure: hours
78
(74 to 95)
78
(75 to 98)
4.Other Pre-specified Outcome
Title Total Amount of Ibuprofen During Inpatient Stay
Hide Description Patients will have access to ibuprofen for mild to moderate pain. The amount consumed during inpatient stay will be collected.
Time Frame 2-7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Overall Number of Participants Analyzed 57 47
Mean (Standard Deviation)
Unit of Measure: mg
4786  (2333) 5260  (1915)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Normal Saline
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

Placebo: 100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

All-Cause Mortality
IV Acetaminophen Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/67 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IV Acetaminophen Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/65 (0.00%)   0/67 (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: Clinical Research Specialist
Organization: TriHealth
Phone: 513-862-2341
EMail: ganga_devaiah@trihealth.com
Layout table for additonal information
Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT02046382     History of Changes
Other Study ID Numbers: 13068
First Submitted: January 23, 2014
First Posted: January 27, 2014
Results First Submitted: November 3, 2017
Results First Posted: January 23, 2018
Last Update Posted: August 16, 2018