NCT01948505

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

May 1, 2018

Enrollment Period

3.3 years

First QC Date

September 18, 2013

Results QC Date

May 7, 2018

Last Update Submit

April 20, 2023

Conditions

Post-operative Craniotomy PatientsCarotid Endarterectomy and Carotid Artery Stenosis PatientsPost-op Spine Patients Admitted to the NCCUEndovascular Patients Undergoing Intracranial InterventionTraumatic Brain Injuries NPO for at Least 12 Hours

Keywords

Craniotomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours

Other Outcomes (1)

  • Frequency of Nausea, Vomiting, Urinary Retention & Constipation

    48 hours

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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 Group

PLACEBO COMPARATOR

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

Interventions

Intravenous acetaminophenDRUG
Intervention group
Placebo for IV acetaminophenDRUG
Also known as: Normal Saline
Placebo Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • 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. 2019 Mar 1;130(3):766-722. doi: 10.3171/2017.10.JNS171464. Epub 2018 Apr 20.

    PMID: 29676689DERIVED

MeSH Terms

Interventions

AcetaminophenSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Caveats, a maximum of 3 g of IV acetaminophen was used to minimize the chance for acetaminophen-related toxicity and comply with current dosage recommendations of our university pharmacy.

Results Point of Contact

Title
Dr. Walavan Sivakumar
Organization
Pacific Neuroscience Institute
walavan.sivakumar@gmail.com
424-212-5361

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 23, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

April 24, 2023

Results First Posted

April 24, 2023

Record last verified: 2018-05

Locations

US(1)