Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU, Endovascular Patients Undergoing Intracranial Intervention, Traumatic Brain Injuries NPO for at Least 12 Hours
Conditions
Keywords
Craniotomy
Brief summary
To assess the efficacy of an intravenous nonnarcotic pain medication on controlling patient pain. To assess the effect of an intravenous nonnarcotic pain medication on patient sedation levels in neurocritically ill patients. To assess the effect of an intravenous nonnarcotic pain medication on common side effects seen in patients taking other intravenous narcotic pain medication in the neurocritical care unit.
Interventions
DRUGPlacebo for IV acetaminophen
Sponsors
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* \> 45 kg (amenable to adult dosing) * all traumatic brain injuries NPO for at least 12 hours * all post-operative craniotomy patients * all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients * all carotid endarterectomy and carotid artery stenosis patients * all endovascular patients undergoing intracranial intervention * all post-op spine patients admitted to the NCCU
Exclusion criteria
* documented allergy to acetaminophen * documented severe hepatic impairment (Child-Pugh score \> 6) or severe hepatic disease (hepatitis) * documented severe renal impairment (CrCl \< 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment. * patients who are pregnant or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Requirement After Surgery | 48 hours | 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. |
Other
| Measure | Time frame |
|---|---|
| Frequency of Nausea, Vomiting, Urinary Retention & Constipation | 48 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 102 |
| 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 | 102 |
| Total | 204 |
Baseline characteristics
| Characteristic | Experimental Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 50.6 years | 50.3 years | 50.5 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 71 Participants | 54 Participants | 125 Participants |
| Sex: Female, Male Male | 31 Participants | 48 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 105 |
| other Total, other adverse events | 0 / 105 | 0 / 105 |
| serious Total, serious adverse events | 0 / 105 | 0 / 105 |
Outcome results
Primary
Narcotic Requirement After Surgery
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.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Experimental Group | Narcotic Requirement After Surgery | 123.5 Morphine Equivalents |
| Placebo Group | Narcotic Requirement After Surgery | 134.2 Morphine Equivalents |
Other Pre-specified
Frequency of Nausea, Vomiting, Urinary Retention & Constipation
Time frame: 48 hours