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Acetaminophen Given Per Os and Intravenous in Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03295214
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : April 10, 2019
Information provided by (Responsible Party):
Luliu Fat, Massachusetts Eye and Ear Infirmary

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.

Condition or disease Intervention/treatment Phase
Acetaminophen Drug: Acetaminophen Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acetaminophen 975mg Per Os
975mg of Acetaminophen given by mouth
Drug: Acetaminophen
Acetaminophen given for pain relief

Active Comparator: Acetaminophen 1000mg Intravenous
1000mg of Acetaminophen given intravenously
Drug: Acetaminophen
Acetaminophen given for pain relief

Primary Outcome Measures :
  1. VAS for pain [ Time Frame: 0-1 hour ]
    First VAS pain score applied

Secondary Outcome Measures :
  1. Opioid Use [ Time Frame: 24 hours ]
    Postoperative opioid consumption for pain control

  2. Time in PACU [ Time Frame: 3-5 hours ]
    Time required to be admitted and discharged home

  3. VAS for pain [ Time Frame: 1-2 hours ]
    Second VAS pain score applied

  4. VAS for pain [ Time Frame: 2-3 hours ]
    Third VAS pain score applied

  5. VAS for pain [ Time Frame: 24 hours ]
    Last VAS pain score applied

  6. PONV [ Time Frame: 24 hours ]
    Incidence of PONV

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03295214

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Contact: Amy Quinkert, PhD 6175734192
Contact: Iuliu Fat, MD 617-573-3380

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United States, Massachusetts
Massachusetts Eye and Ear Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brendan McBrine, BS    617-573-6815   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
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Principal Investigator: Iuliu Fat, MD MEEI
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Responsible Party: Luliu Fat, Principal Investigator, Massachusetts Eye and Ear Infirmary Identifier: NCT03295214    
Other Study ID Numbers: 1098410
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luliu Fat, Massachusetts Eye and Ear Infirmary:
Functional Endoscopic Sinus Surgery
Additional relevant MeSH terms:
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Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs