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Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit

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ClinicalTrials.gov Identifier: NCT01948505
Recruitment Status : Completed
First Posted : September 23, 2013
Last Update Posted : December 9, 2016
Sponsor:
Information provided by (Responsible Party):
Walavan Sivakumar, 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.


Condition or disease Intervention/treatment Phase
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 Drug: Intravenous acetaminophen Drug: Placebo for IV acetaminophen Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intervention group
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
Placebo Comparator: Placebo Group
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
Other Name: Normal Saline




Primary Outcome Measures :
  1. Level of pain as measured on the 0-10 Numeric Rating Scale (NRS) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Sedation level as measured on the Riker Scale (1-7) [ Time Frame: 48 hours ]

Other Outcome Measures:
  1. Frequency of nausea, vomiting, urinary retention & constipation [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948505


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah

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Responsible Party: Walavan Sivakumar, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01948505     History of Changes
Other Study ID Numbers: 00061838
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016

Keywords provided by Walavan Sivakumar, University of Utah:
Craniotomy

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Carotid Stenosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Carotid Artery Diseases
Cerebrovascular Disorders
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics