NCT03295214

Brief Summary

The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the investigators can produce the maximal amount of pain relief after surgery while making conscientious monetary decisions.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

September 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

March 28, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

September 21, 2017

Last Update Submit

April 8, 2019

Conditions

Acetaminophen

Keywords

AcetaminophenFunctional Endoscopic Sinus Surgery

Outcome Measures

Primary Outcomes (1)

  • VAS for pain

    First VAS pain score applied

    0-1 hour

Secondary Outcomes (6)

  • Opioid Use

    24 hours

  • Time in PACU

    3-5 hours

  • VAS for pain

    1-2 hours

  • VAS for pain

    2-3 hours

  • VAS for pain

    24 hours

  • +1 more secondary outcomes

Study Arms (2)

Acetaminophen 975mg Per Os

ACTIVE COMPARATOR

975mg of Acetaminophen given by mouth

Drug: Acetaminophen

Acetaminophen 1000mg Intravenous

ACTIVE COMPARATOR

1000mg of Acetaminophen given intravenously

Drug: Acetaminophen

Interventions

AcetaminophenDRUG

Acetaminophen given for pain relief

Acetaminophen 1000mg IntravenousAcetaminophen 975mg Per Os

Eligibility Criteria

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

You may qualify if:

  • Willingness to participate
  • Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)
  • Over the age of 18 during time of surgery
  • Weighing over 50kg

You may not qualify if:

  • Severe hepatic impairment or active liver disease
  • Known hypersensitivity to acetaminophen or to any excipients in the intravenous formulation
  • chronic opioid use
  • chronic pain
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (3)

  • Carroll NV, Miederhoff PA, Cox FM, Hirsch JD. Costs incurred by outpatient surgical centers in managing postoperative nausea and vomiting. J Clin Anesth. 1994 Sep-Oct;6(5):364-9. doi: 10.1016/s0952-8180(05)80004-2.

    PMID: 7986507BACKGROUND

  • DeLoach LJ, Higgins MS, Caplan AB, Stiff JL. The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998 Jan;86(1):102-6. doi: 10.1097/00000539-199801000-00020.

    PMID: 9428860BACKGROUND

  • Fenlon S, Collyer J, Giles J, Bidd H, Lees M, Nicholson J, Dulai R, Hankins M, Edelman N. Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior? Br J Anaesth. 2013 Mar;110(3):432-7. doi: 10.1093/bja/aes387. Epub 2012 Dec 6.

    PMID: 23220855BACKGROUND

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Iuliu Fat, MD

    MEEI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Quinkert, PhD

CONTACT

6175734192amy_quinkert@meei.harvard.edu

Iuliu Fat, MD

CONTACT

617-573-3380iuliu_fat@meei.harvard.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 27, 2017

Study Start

March 28, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)