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Pharmacoeconomics and Related Patient Outcomes of Multi-dose Intravenous Acetaminophen (OFIRMEV)

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ClinicalTrials.gov Identifier: NCT02369211
Recruitment Status : Completed
First Posted : February 23, 2015
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Richard D Urman, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Prostatectomy
Pain
Interventions Drug: Acetaminophen (Ofirmev)
Other: Placebo
Enrollment 86
Recruitment Details Patients were recruited in the preoperative assessment clinic prior to undergoing surgery
Pre-assignment Details  
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Period Title: Overall Study
Started 43 43
Completed 43 41
Not Completed 0 2
Arm/Group Title Intravenous Acetaminophen Placebo Total
Hide Arm/Group Description

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 43 41 84
Hide Baseline Analysis Population Description
analysis population is the same as the assignment in Participant flow
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 41 participants 84 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
  32.6%
16
  39.0%
30
  35.7%
>=65 years
29
  67.4%
25
  61.0%
54
  64.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 41 participants 84 participants
63.6  (6.1) 60.2  (6.3) 61.7  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 41 participants 84 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
43
 100.0%
41
 100.0%
84
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants 41 participants 84 participants
43 41 84
1.Primary Outcome
Title Post Anesthesia Care Unit Length of Stay
Hide Description The amount of time patients stayed in the post-anesthesia care unit following anesthesia, before going to the inpatient ward.
Time Frame approximately 30-240 min
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had surgery and were then transferred to the post-anesthesia care unit for recovery.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Overall Number of Participants Analyzed 34 41
Mean (Standard Deviation)
Unit of Measure: minutes
124  (58.26) 132  (62.58)
2.Primary Outcome
Title Hospital Length of Stay
Hide Description This outcome measure calculates the number of days the patient stayed in the hospital before being discharged home.
Time Frame 1-3 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were admitted to the hospital (as inpatients) following surgery and post-anesthesia care unit stay.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Overall Number of Participants Analyzed 34 41
Median (95% Confidence Interval)
Unit of Measure: Days
0.81
(0.71 to 0.90)
0.82
(0.66 to 0.95)
3.Secondary Outcome
Title Pain Score
Hide Description

Pain scores were collected using the Visual Analog Scale. The scale range is 0 (no pain) to 10 (most pain).

Mean pain score over first 24 hours postoperatively was collected.

Time Frame 0-24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who were assessed for levels of pain following surgery, including both treatment and placebo arms.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Overall Number of Participants Analyzed 41 43
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
0.62
(0.13 to 1.00)
0.88
(0.38 to 2.00)
4.Secondary Outcome
Title Opioid Use
Hide Description A measure of the amount of opioid study patients used postoperatively while recovering from surgery at the hospital
Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who underwent surgery and stayed in the hospital as inpatients and received pain management.
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description:

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

Overall Number of Participants Analyzed 43 41
Median (Inter-Quartile Range)
Unit of Measure: morphine milligram equivalents
42
(36.4 to 50.0)
50
(35.6 to 72.0)
Time Frame Patients were followed for 30 days after surgery for which adverse events were collected.
Adverse Event Reporting Description Same definition of adverse event was used.
 
Arm/Group Title Intravenous Acetaminophen Placebo
Hide Arm/Group Description

Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)

Patient receives saline injection instead of the study drug

Placebo

All-Cause Mortality
Intravenous Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/41 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/41 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James Webber
Organization: Brigham and Women's Hospital
Phone: (617) 732-6877
EMail: jwebber1@partners.org
Layout table for additonal information
Responsible Party: Richard D Urman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02369211     History of Changes
Other Study ID Numbers: 2014P002749
First Submitted: February 17, 2015
First Posted: February 23, 2015
Results First Submitted: August 3, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019