NCT02643394

Brief Summary

The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown. In this observer blinded randomized clinical trial, investigators aim to determine the comparative efficacy of PO (preoperative) vs. IV (intraoperative) acetaminophen in a sinus surgery population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Aug 2015

Longer than P75 for phase_4 postoperative-pain

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

June 2, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

August 17, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 7, 2018

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

June 2, 2015

Results QC Date

November 10, 2017

Last Update Submit

April 20, 2020

Conditions

Postoperative Pain

Keywords

AcetaminophenPostoperative painSinus Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score on the Scale of 10 (0=No Pain and 10=Worst Pain)

    Pain score on the scale of 10 at 1-h postoperatively in the Post-Anesthesia Care Unit (PACU)

    1-h postoperatively

Secondary Outcomes (1)

  • Morphine Equivalents of Postoperative Opioid Usage

    an expected average of 6 hours

Study Arms (2)

Oral Acetaminophen

ACTIVE COMPARATOR

Oral Acetaminophen 1-hour before surgery

Drug: Oral Acetaminophen

Intravenous Acetaminophen

ACTIVE COMPARATOR

Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Drug: Intravenous acetaminophen

Interventions

Oral AcetaminophenDRUG

1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision

Also known as: Tylenol
Oral Acetaminophen
Intravenous acetaminophenDRUG

400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.

Also known as: Tylenol
Intravenous Acetaminophen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 years or older
  • Undergoing elective sinus surgery at Zale Lipshy Hospital

You may not qualify if:

  • Inability of the patient to follow directions or comprehend either English or Spanish language.
  • Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
  • Patients with chronic pain manifest by a baseline pain score \> 4/10
  • Chronic opioid use (\>2 weeks continuously), or illicit drug abuse
  • Body weight \< 50 kg.
  • Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
  • Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
  • Allergy to acetaminophen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zale Lipshy University Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Single center Sinus surgery population only

Results Point of Contact

Title
David McDonagh, MD
Organization
UT Southwestern Medical Center
david.mcdonagh@utsouthwestern.edu
214-648-8083

Study Officials

  • David McDonagh, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

December 31, 2015

Study Start

August 17, 2015

Primary Completion

September 2, 2016

Study Completion

January 15, 2018

Last Updated

April 21, 2020

Results First Posted

May 7, 2018

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)