Back to resultsEffect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Primary Purpose
Post-operative Craniotomy Patients, Carotid Endarterectomy and Carotid Artery Stenosis Patients, Post-op Spine Patients Admitted to the NCCU
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intravenous acetaminophen
Placebo for IV acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Craniotomy Patients focused on measuring Craniotomy
Eligibility 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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention group
Placebo Group
Arm Description
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
IV Normal Saline: 100ml IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01948505
Brief Title
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
Craniotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Intravenous acetaminophen
Intervention Type
Drug
Intervention Name(s)
Placebo for IV acetaminophen
Other Intervention Name(s)
Normal Saline
Primary Outcome Measure Information:
Title
Narcotic Requirement After Surgery
Description
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.
Time Frame
48 hours
Other Pre-specified Outcome Measures:
Title
Frequency of Nausea, Vomiting, Urinary Retention & Constipation
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29676689
Citation
Sivakumar W, Jensen M, Martinez J, Tanana M, Duncan N, Hoesch R, Riva-Cambrin JK, Kilburg C, Ansari S, House PA. Intravenous acetaminophen for postoperative supratentorial craniotomy pain: a prospective, randomized, double-blinded, placebo-controlled trial. J Neurosurg. 2018 Apr 20;130(3):766-722. doi: 10.3171/2017.10.JNS171464.
Results Reference
derived
Learn more about this trial
Effect of IV Acetaminophen on Patients in the Neurocritical Care Unit
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