Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

Phase 4

Completed

• Conditions: 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
• Interventions: Drug: Placebo for IV acetaminophen; Drug: Intravenous acetaminophen

• Registration Number: NCT01948505
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-18
• Study First Submitted QC: 2013-09-20
• Study First Posted: 2013-09-23
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2018-05
• Results First Submitted: 2018-05-07
• Results First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Results First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo for IV acetaminophen	IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Intervention group	Intravenous acetaminophen	IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States