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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
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
- Level of pain as measured on the 0-10 Numeric Rating Scale (NRS) [ Time Frame: 48 hours ]
- Sedation level as measured on the Riker Scale (1-7) [ Time Frame: 48 hours ]
- Frequency of nausea, vomiting, urinary retention & constipation [ Time Frame: 48 hours ]
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
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|