Acetaminophen Given Per Os and Intravenous in Sinus Surgery | NCT03295214

Studies
Acetaminophen Given Per Os and Intravenous in Sinus Surgery

NCT03295214

Sponsor

Massachusetts Eye and Ear Infirmary

Status

Unknown status

Last Update Posted

Apr 10, 2019Actual

Enrollment

124Estimated

Phase

Phase 3

Conditions

Acetaminophen

Interventions

Acetaminophen

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 28, 2018Actual

Primary Completion Date

Mar 2020Estimated

Completion Date

Mar 2020Estimated

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 22, 2017

First Posted Date

Sep 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 8, 2019

Last Update Posted Date

Apr 10, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luliu Fat, Principal Investigator, Massachusetts Eye and Ear InfirmaryPrincipal Investigator

Lead Sponsor

Massachusetts Eye and Ear InfirmaryOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat Surgeries done in the United States annually. This procedure can vary from intense to moderate pain and as such it is difficult to properly gauge and treat postoperative pain in these patients. Commonly used in these cases, opioid drugs are given to provide adequate analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV). Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid sparing properties.

Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter. Its properties include analgesic and antipyretic qualities and it is listed on the world health organization's list of essential medicines. The potential risks include liver damage, skin reactions and drug interactions when used with blood thinners at high doses. Acetaminophen has been extensively researched, in vitro and in vivo studies have found the drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has gained popularity due to ease of use and ability to be given intraoperatively. This form of acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen. Due to this increased cost it is imperative that the investigators compare the two routes of administration in order to determine if the additional cost is justified.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Acetaminophen	Drug	Acetaminophen given for pain relief	Acetaminophen 1000mg Intravenous Acetaminophen 975mg Per Os

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS for pain	First VAS pain score applied	0-1 hour

Secondary Outcomes

Measure	Description	Time Frame
Opioid Use	Postoperative opioid consumption for pain control	24 hours
Time in PACU	Time required to be admitted and discharged home

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amy Quinkert, PhD	Contact	6175734192		amy_quinkert@meei.harvard.edu
Iuliu Fat, MD	Contact	617-573-3380		iuliu_fat@meei.harvard.edu

Overall Officials

Name	Affiliation	Role
Iuliu Fat, MD	MEEI	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts Eye and Ear	Recruiting	Boston	Massachusetts	02114	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7986507	Background	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.
9428860	Background	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.

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814