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OpenTrials
Completed

NCT Number: NCT01948505

Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Utah

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous acetaminophen

Drug

Placebo for IV acetaminophen

Drug

Other names: Normal Saline

Primary outcomes

  1. Narcotic Requirement After Surgery

    Time frame: 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 outcomes

  1. Frequency of Nausea, Vomiting, Urinary Retention & Constipation

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 23, 2013
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.