Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 1877 for:    Acetaminophen

RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

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: NCT02043704
Recruitment Status : Completed
First Posted : January 23, 2014
Results First Posted : March 14, 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
Condition Post Operative Pain
Intervention Drug: IV Acetaminophen
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Period Title: Overall Study
Started 50 50
Completed 47 43
Not Completed 3 7
Arm/Group Title IV Acetaminophen Saline Total
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Total of all reporting groups
Overall Number of Baseline Participants 47 43 90
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 43 participants 90 participants
57.3  (12.8) 59.4  (11.4) 58.3  (12.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 43 participants 90 participants
Female
47
 100.0%
43
 100.0%
90
 100.0%
Male
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 43 participants 90 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
47
 100.0%
43
 100.0%
90
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 47 participants 43 participants 90 participants
47
 100.0%
43
 100.0%
90
 100.0%
1.Primary Outcome
Title Pain While Active - 18 hr
Hide Description Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active.
Time Frame 18 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Median (Inter-Quartile Range)
Unit of Measure: mm
42.0
(27.5 to 61)
50.0
(28.5 to 71.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Saline
Comments The comparison was analyzed using the Mann-Whitney U test.
Type of Statistical Test Equivalence
Comments The null hypothesis is that there is no difference in the pain scores between the groups.
Statistical Test of Hypothesis P-Value 0.328
Comments The p-value was not adjusted for multiple comparisons.
Method Wilcoxon (Mann-Whitney)
Comments There were no adjustments.
2.Primary Outcome
Title Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Hide Description Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Median (Inter-Quartile Range)
Unit of Measure: mgs
13
(6.67 to 26.68)
15
(5 to 26.67)
3.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Count reported for nausea/vomiting.
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
27
  57.4%
22
  51.2%
4.Secondary Outcome
Title Time to First Rescue Narcotic
Hide Description The time from the end of surgery to the time any IV narcotic is given.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Median (Inter-Quartile Range)
Unit of Measure: minutes
27
(18 to 64)
41
(22 to 67)
5.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for itching.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
11
  23.4%
5
  11.6%
6.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for headache.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
6
  12.8%
3
   7.0%
7.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for insomnia.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
8
  17.0%
2
   4.7%
8.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for rash/hives.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
9.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for shortness of breath.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
4
   8.5%
0
   0.0%
10.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for respiratory depression.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Narcotic Associated Side Effects
Hide Description The incidence of known narcotic associated side effects will be recorded for urinary retention.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Measure Type: Count of Participants
Unit of Measure: Participants
29
  61.7%
20
  46.5%
12.Secondary Outcome
Title Time to Ambulation
Hide Description Length of time from the end of surgery to the time of ambulation.
Time Frame 1800 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Median (Inter-Quartile Range)
Unit of Measure: minutes
1295
(1108 to 1462)
1252
(778 to 1459)
13.Other Pre-specified Outcome
Title Time to First Flatus/Bowel Movement
Hide Description Length of time from the end of surgery to the time of first flatus or bowel movement.
Time Frame 9000 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description:

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Overall Number of Participants Analyzed 47 43
Median (Inter-Quartile Range)
Unit of Measure: minutes
3977
(1437 to 5564)
1899
(1275 to 4580)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Saline
Hide Arm/Group Description

Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.

All-Cause Mortality
IV Acetaminophen Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (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 Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (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: NCT02043704     History of Changes
Other Study ID Numbers: 13072
First Submitted: January 21, 2014
First Posted: January 23, 2014
Results First Submitted: October 11, 2017
Results First Posted: March 14, 2018
Last Update Posted: August 16, 2018