Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Carotid Endarterectomy and Carotid Artery Stenosis Patients Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948505
• Other study ID #: 00061838
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: November 2016

Study information

• Verified date: May 2018
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Intravenous acetaminophen

• Placebo for IV acetaminophen

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of Nausea, Vomiting, Urinary Retention & Constipation		48 hours
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.	48 hours