NCT01544062

Brief Summary

Patients undergoing cardiac surgery experience significant postoperative pain, which may impact postoperative outcomes. The aim of this single center, double-blind, randomized, placebo controlled trial is to determine if intravenous (IV) acetaminophen will significantly decrease 24 hour postoperative opioid consumption.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

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

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 21, 2016

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

February 28, 2012

Results QC Date

November 30, 2015

Last Update Submit

May 12, 2016

Conditions

Acute PainHyperalgesia

Keywords

Cardiac surgeryAcute PainWound HyperalgesiaIntravenous AcetaminophenPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Postoperative Opioid Consumption

    The 24 hour postoperative opioid consumption will be obtained from the electronic medication administration record and expressed in morphine equivalents.

    24 hours after arriving in ICU

Secondary Outcomes (20)

  • 48 Hour Postoperative Opioid Consumption

    48 hours after arriving in ICU

  • 24 Hour Postoperative Pain Scores at Rest

    24 hours after arriving in ICU

  • 48 Hour Postoperative Pain Scores at Rest

    48 hours after arriving in ICU

  • 24 Hour Postoperative Pain Scores With Movement

    24 hours after arriving in ICU

  • 48 Hour Postoperative Pain Scores With Movement

    48 hours after arriving in ICU

  • +15 more secondary outcomes

Study Arms (2)

IV acetaminophen

EXPERIMENTAL

Study subjects receiving IV acetaminophen

Drug: IV acetaminophen

Normal saline

PLACEBO COMPARATOR

Study subjects receiving placebo

Drug: Placebo

Interventions

IV acetaminophenDRUG

Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Also known as: Ofirmev
IV acetaminophen
PlaceboDRUG

Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.

Normal saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) subjects who clinically consented to elective sternotomy for coronary artery bypass grafting (CABG), heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years

You may not qualify if:

  • (1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center, Department of ANesthesiology and Pain Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Acute PainHyperalgesiaPatient Satisfaction

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSomatosensory DisordersSensation DisordersNervous System DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

* several subjects received intraoperative hydromorphone while others only received intraoperative fentanyl * significantly greater proportion of females in the placebo group

Results Point of Contact

Title
Srdjan Jelacic, MD
Organization
University of Washington
sjelacic@uw.edu
(206) 598-3777

Study Officials

  • Lisa Flint, BS

    University of Washington

    STUDY DIRECTOR

  • Srdjan Jelacic, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

July 1, 2012

Primary Completion

December 1, 2013

Study Completion

August 1, 2014

Last Updated

June 21, 2016

Results First Posted

June 21, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)