Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 4

Conditions: Post-op Spine Patients Admitted to the NCCU; Endovascular Patients Undergoing Intracranial Intervention; Post-operative Craniotomy Patients; Traumatic Brain Injuries NPO for at Least 12 Hours; Carotid Endarterectomy and Carotid Artery Stenosis Patients

Treatments: Drug: Placebo for IV acetaminophen; Drug: Intravenous acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT01948505

00061838

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

Intervention group

Active Comparator group

Description:

IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Treatment:

Drug: Intravenous acetaminophen

Placebo Group

Placebo Comparator group

Description:

IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Treatment:

Drug: Placebo for IV acetaminophen