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Trial record 55 of 1888 for:    Acetaminophen

Efficacy of IV Acetaminophen for Pain Management

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ClinicalTrials.gov Identifier: NCT02028715
Recruitment Status : Completed
First Posted : January 7, 2014
Results First Posted : December 25, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Aultman Health Foundation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Supportive Care
Condition Post-operative Pain
Interventions Drug: Placebo
Drug: IV acetaminophen
Enrollment 68
Recruitment Details 68 participants were enrolled between December 2013 and May 2014 at local institution
Pre-assignment Details  
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Period Title: Overall Study
Started 34 34
Completed 29 30
Not Completed 5 4
Reason Not Completed
Adverse Event             2             2
Physician Decision             1             0
Did not complete satisfaction surveys             2             2
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen) Total
Hide Arm/Group Description

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Total of all reporting groups
Overall Number of Baseline Participants 29 30 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 59 participants
50.34  (16.101) 51.73  (12.690) 51.05  (14.358)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 59 participants
Female
29
 100.0%
30
 100.0%
59
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
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: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 30 participants 59 participants
29
 100.0%
30
 100.0%
59
 100.0%
1.Primary Outcome
Title Opioid Rescue - 48 Hours
Hide Description Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
Time Frame First 48 hours including pre-operative and intra-operative medications
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Milligrams of intravenous morphine equiv
54.4803  (22.86841) 48.9253  (22.94435)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .356
Comments [Not Specified]
Method t-test for Equality of Means
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.55501
Confidence Interval (2-Sided) 95%
-6.39040 to 17.50042
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.96535
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Return of Bowel Function
Hide Description Time to return of bowel function (passage of flatus) in hours
Time Frame Duration of hospital stay (up to 7 days).
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants with documented return of bowel function prior to discharge were analyzed.
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 26 28
Mean (Standard Deviation)
Unit of Measure: Hours
68.0878  (22.99293) 56.5696  (27.88443)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .105
Comments [Not Specified]
Method t-test for Equality of Means
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 11.51818
Confidence Interval (2-Sided) 95%
-2.49963 to 25.53599
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.98569
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
Hide Description Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
Time Frame At 24 hours 48 hours, and discharge (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the pain satisfaction survey at 24 hours
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 24 hours 4.21  (.721) 4.19  (1.021)
At 48 hours 4.08  (.881) 4.04  (.824)
At Discharge 4.58  (.654) 4.23  (.951)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .029
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
Hide Description Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
Time Frame At 24 hours, 48 Hours, and Discharge (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the nausea control survey.
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 24 hours 3.88  (.900) 3.73  (1.041)
At 48 hours 4.12  (.992) 3.50  (1.068)
At Discharge 4.17  (.761) 3.65  (.797)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.
Statistical Test of Hypothesis P-Value .643
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
Hide Description Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
Time Frame At 24 hours, 48 Hours, and Discharge (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the bloating satisfaction survey
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 24 hours 3.58  (1.472) 4.23  (.951)
At 48 hours 3.75  (1.152) 3.69  (1.050)
At Discharge 3.79  (1.141) 3.35  (1.093)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.
Statistical Test of Hypothesis P-Value .217
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
Hide Description Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
Time Frame At 24 hours, 48 Hours, and Discharge (up to 7 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the pruritus satisfaction survey
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 24 26
Mean (Standard Deviation)
Unit of Measure: score on a scale
At 24 hours 3.71  (1.459) 3.58  (1.391)
At 48 hours 3.67  (1.404) 3.85  (1.120)
At Discharge 3.54  (1.382) 3.88  (1.177)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Within subjects Analysis of Variance (ANOVA) of time, sphericity assumed, was used for pain, nausea, bloating and pruritus.
Statistical Test of Hypothesis P-Value .647
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Length of Stay
Hide Description Mean length of post-operative stay in days
Time Frame Surgery to discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Participants experiencing adverse event leading to increased length of stay were not analyzed.
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description:

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

Overall Number of Participants Analyzed 29 30
Mean (Standard Deviation)
Unit of Measure: Days
3.62  (1.147) 3.57  (1.305)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental (Normal Saline), Experimental (IV Acetaminophen)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .054
Confidence Interval (2-Sided) 95%
-.587 to .695
Parameter Dispersion
Type: Standard Error of the Mean
Value: .320
Estimation Comments [Not Specified]
Time Frame Surgery to Discharge (up to 7 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental (Normal Saline) Experimental (IV Acetaminophen)
Hide Arm/Group Description

Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.

All-Cause Mortality
Experimental (Normal Saline) Experimental (IV Acetaminophen)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/34 (0.00%)      0/34 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental (Normal Saline) Experimental (IV Acetaminophen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/34 (5.88%)      1/34 (2.94%)    
Blood and lymphatic system disorders     
Pulmonary Embolism   1/34 (2.94%)  1 0/34 (0.00%)  0
Infections and infestations     
Pneumonia   1/34 (2.94%)  1 1/34 (2.94%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental (Normal Saline) Experimental (IV Acetaminophen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      0/34 (0.00%)    
Pain perception and tolerance is an individual characteristics that cannot be controlled. Other limitations include small sample size and reliance on participants to complete surveys at prescribed time.
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: Director of Research Programs
Organization: Aultman Hospital
Phone: 330-363-7274
EMail: mary.amos@aultman.com
Layout table for additonal information
Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT02028715     History of Changes
Other Study ID Numbers: 2013.08.22.F2
First Submitted: January 2, 2014
First Posted: January 7, 2014
Results First Submitted: December 3, 2018
Results First Posted: December 25, 2018
Last Update Posted: January 16, 2019