Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Study Overview
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Brief Summary
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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.

Conditions
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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

Intervention / Treatment
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* Drug: Intravenous acetaminophen
* Drug: Placebo for IV acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication | Drug: Intravenous acetaminophen<br> <br> |
| Placebo Comparator: Placebo Group<br>IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication | Drug: Placebo for IV acetaminophen<br> <br> * Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniotomy