Trial Outcomes & Findings for Efficacy of IV Acetaminophen for Pain Management (NCT NCT02028715)
NCT ID: NCT02028715
Last Updated: 2019-01-16
Results Overview
Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
68 participants
Primary outcome timeframe
First 48 hours including pre-operative and intra-operative medications
Results posted on
2019-01-16
Participant Flow
68 participants were enrolled between December 2013 and May 2014 at local institution
Participant milestones
| Measure |
Experimental (Normal Saline)
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.
|
Experimental (IV Acetaminophen)
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 Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Experimental (Normal Saline)
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.
|
Experimental (IV Acetaminophen)
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 Study
Adverse Event
|
2
|
2
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Did not complete satisfaction surveys
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental (Normal Saline)
n=29 Participants
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.
|
Experimental (IV Acetaminophen)
n=30 Participants
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
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.34 years
STANDARD_DEVIATION 16.101 • n=29 Participants
|
51.73 years
STANDARD_DEVIATION 12.690 • n=30 Participants
|
51.05 years
STANDARD_DEVIATION 14.358 • n=59 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=29 Participants
|
30 Participants
n=30 Participants
|
59 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=29 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=59 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
29 Participants
n=29 Participants
|
30 Participants
n=30 Participants
|
59 Participants
n=59 Participants
|
PRIMARY outcome
Timeframe: First 48 hours including pre-operative and intra-operative medicationsMean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
Outcome measures
| Measure |
Experimental (Normal Saline)
n=29 Participants
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.
|
Experimental (IV Acetaminophen)
n=30 Participants
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.
|
|---|---|---|
|
Opioid Rescue - 48 Hours
|
54.4803 Milligrams of intravenous morphine equiv
Standard Deviation 22.86841
|
48.9253 Milligrams of intravenous morphine equiv
Standard Deviation 22.94435
|
SECONDARY outcome
Timeframe: Duration of hospital stay (up to 7 days).Population: Only participants with documented return of bowel function prior to discharge were analyzed.
Time to return of bowel function (passage of flatus) in hours
Outcome measures
| Measure |
Experimental (Normal Saline)
n=26 Participants
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.
|
Experimental (IV Acetaminophen)
n=28 Participants
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.
|
|---|---|---|
|
Return of Bowel Function
|
68.0878 Hours
Standard Deviation 22.99293
|
56.5696 Hours
Standard Deviation 27.88443
|
SECONDARY outcome
Timeframe: At 24 hours 48 hours, and discharge (up to 7 days)Population: Participants who completed the pain satisfaction survey at 24 hours
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
Outcome measures
| Measure |
Experimental (Normal Saline)
n=24 Participants
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.
|
Experimental (IV Acetaminophen)
n=26 Participants
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.
|
|---|---|---|
|
Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
At 24 hours
|
4.21 score on a scale
Standard Deviation .721
|
4.19 score on a scale
Standard Deviation 1.021
|
|
Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
At 48 hours
|
4.08 score on a scale
Standard Deviation .881
|
4.04 score on a scale
Standard Deviation .824
|
|
Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
At Discharge
|
4.58 score on a scale
Standard Deviation .654
|
4.23 score on a scale
Standard Deviation .951
|
SECONDARY outcome
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)Population: Participants who completed the nausea control survey.
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
Outcome measures
| Measure |
Experimental (Normal Saline)
n=24 Participants
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.
|
Experimental (IV Acetaminophen)
n=26 Participants
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.
|
|---|---|---|
|
Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
At 24 hours
|
3.88 score on a scale
Standard Deviation .900
|
3.73 score on a scale
Standard Deviation 1.041
|
|
Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
At 48 hours
|
4.12 score on a scale
Standard Deviation .992
|
3.50 score on a scale
Standard Deviation 1.068
|
|
Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
At Discharge
|
4.17 score on a scale
Standard Deviation .761
|
3.65 score on a scale
Standard Deviation .797
|
SECONDARY outcome
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)Population: Participants who completed the bloating satisfaction survey
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
Outcome measures
| Measure |
Experimental (Normal Saline)
n=24 Participants
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.
|
Experimental (IV Acetaminophen)
n=26 Participants
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.
|
|---|---|---|
|
Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
At 24 hours
|
3.58 score on a scale
Standard Deviation 1.472
|
4.23 score on a scale
Standard Deviation .951
|
|
Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
At 48 hours
|
3.75 score on a scale
Standard Deviation 1.152
|
3.69 score on a scale
Standard Deviation 1.050
|
|
Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
At Discharge
|
3.79 score on a scale
Standard Deviation 1.141
|
3.35 score on a scale
Standard Deviation 1.093
|
SECONDARY outcome
Timeframe: At 24 hours, 48 Hours, and Discharge (up to 7 days)Population: Participants who completed the pruritus satisfaction survey
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
Outcome measures
| Measure |
Experimental (Normal Saline)
n=24 Participants
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.
|
Experimental (IV Acetaminophen)
n=26 Participants
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.
|
|---|---|---|
|
Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
At 24 hours
|
3.71 score on a scale
Standard Deviation 1.459
|
3.58 score on a scale
Standard Deviation 1.391
|
|
Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
At 48 hours
|
3.67 score on a scale
Standard Deviation 1.404
|
3.85 score on a scale
Standard Deviation 1.120
|
|
Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
At Discharge
|
3.54 score on a scale
Standard Deviation 1.382
|
3.88 score on a scale
Standard Deviation 1.177
|
SECONDARY outcome
Timeframe: Surgery to dischargePopulation: Participants experiencing adverse event leading to increased length of stay were not analyzed.
Mean length of post-operative stay in days
Outcome measures
| Measure |
Experimental (Normal Saline)
n=29 Participants
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.
|
Experimental (IV Acetaminophen)
n=30 Participants
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.
|
|---|---|---|
|
Length of Stay
|
3.62 Days
Standard Deviation 1.147
|
3.57 Days
Standard Deviation 1.305
|
Adverse Events
Experimental (Normal Saline)
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental (IV Acetaminophen)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental (Normal Saline)
n=34 participants at risk
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.
|
Experimental (IV Acetaminophen)
n=34 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
2.9%
1/34 • Number of events 1 • Surgery to Discharge (up to 7 days)
|
2.9%
1/34 • Number of events 1 • Surgery to Discharge (up to 7 days)
|
|
Blood and lymphatic system disorders
Pulmonary Embolism
|
2.9%
1/34 • Number of events 1 • Surgery to Discharge (up to 7 days)
|
0.00%
0/34 • Surgery to Discharge (up to 7 days)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place