Trial Outcomes & Findings for Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit (NCT NCT01948505)
NCT ID: NCT01948505
Last Updated: 2023-04-24
Results Overview
The primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.
COMPLETED
PHASE4
210 participants
48 hours
2023-04-24
Participant Flow
Participant milestones
| Measure |
Experimental Group
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Intravenous acetaminophen
|
Placebo Group
IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Placebo for IV acetaminophen
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
105
|
|
Overall Study
COMPLETED
|
105
|
105
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=102 Participants
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Intravenous acetaminophen
|
Placebo Group
n=102 Participants
IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Placebo for IV acetaminophen
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.6 years
n=102 Participants
|
50.3 years
n=102 Participants
|
50.5 years
n=204 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=102 Participants
|
54 Participants
n=102 Participants
|
125 Participants
n=204 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=102 Participants
|
48 Participants
n=102 Participants
|
79 Participants
n=204 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 48 hoursThe primary efficacy end point was narcotic consumption during the first 48 hours after craniotomy. Opioid usage was calculated by converting the amount of the narcotics taken by the patient into oral morphine equivalents (ME), which were totaled for each postoperative day. At 48 hours after surgery, patients who received IV acetaminophen in addition to our standardized pain protocol did not have a statistically significantly lower mean narcotic requirement, measured in ME, when compared with those in the placebo group.
Outcome measures
| Measure |
Experimental Group
n=102 Participants
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Intravenous acetaminophen
|
Placebo Group
n=102 Participants
IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Placebo for IV acetaminophen
|
|---|---|---|
|
Narcotic Requirement After Surgery
|
123.5 Morphine Equivalents
Interval 102.9 to 144.2
|
134.2 Morphine Equivalents
Interval 112.1 to 156.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 hoursOutcome measures
Outcome data not reported
Adverse Events
Experimental Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place