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Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery (IVAPAP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
Cadence Pharmaceuticals
Information provided by (Responsible Party):
Davide Cattano, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01608308
First received: May 25, 2012
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to assess the use of IV acetaminophen (Ofirmev) as a and safe and efficacious agent in reducing post-operative pain; we hypothesize that its use will reduce post-operative pain by 50% when compared to a control group using the VAS analog pain scoring system.


Condition Intervention
Chronic Sinusitis
Drug: IV Acetaminophen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Double Blind, Randomized, Placebo-controlled Study to Investigate the Effectiveness of IV Acetominophen Administered During Functional Endoscopic Sinus Surgery in Reducing the Use of Opiates to Treat Postoperative Pain

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Assess the efficacy of IV acetaminophen in controlling postoperative pain [ Time Frame: 4 Hours Post-Operatively ] [ Designated as safety issue: No ]
    Pain will be assessed using a VAS Scale at regular time intervals post-operatively.


Secondary Outcome Measures:
  • Investigate the effect of IV acetaminophen on the use of postoperative opioid analgesics [ Time Frame: During PACU Stay (Approximately 4 hours) ] [ Designated as safety issue: No ]
    The total amount of postoperative opioid use will be recorded as follows: after the patient has arrived in the PACU (post anesthesia care unit), the incidence and intensity of pain will be assessed using a VAS (0-100) as described above. Pain relief will be achieved by incremental doses of morphine 1 mg bolus, based on a VAS score of 40 and above, to be repeated every 5 minutes if needed. The total amount of morphine utilized in PACU will be recorded.

  • Analyze effects of IV acetaminophen on intraoperative analgesic use [ Time Frame: Duration of Surgery (Approximately 3-4 Hours) ] [ Designated as safety issue: No ]
    Brief episodes of tachycardia and hypertension are expected in FESS procedures. These will be treated by increasing inhalational agents of 0.5% inspired fraction at a time. A supplemental dose of fentanyl in the amount of 1 mcg/kg will be available for HR and BP greater than 15-20% above baseline after no response to volatile change. The following measurements will be recorded: total amount of fentanyl utilized; the hemodynamic parameters during surgery and anesthesia; the inspired fraction of inhalational agent; and the number of step-wise increases for hemodynamic control.

  • Identify potential correlation between vital signs and postoperative pain intensity [ Time Frame: Duration of PACU Stay (Approximately 4 Hours Post-Operatively) ] [ Designated as safety issue: No ]
    The association of postoperative pain intensity with vital sign changes (including heart rate, respiratory rate, blood pressure, and temperature) will be assessed. Each patient's vital signs will be collected at the specified time points, in addition to measuring pain intensity using the VAS scale. Data will be collected and analyzed to search for a statistical correlation between postoperative pain intensity and vital sign changes.

  • Examine the effect of IV acetaminophen on post-operative quality of recovery [ Time Frame: Upto 48 Hours Post-Operatively ] [ Designated as safety issue: No ]

    Adverse events including, dizziness, nausea/vomiting, tachy/brady-cardia, arrhythmia, hypertension, hypotension, allergic reaction, etc. will be monitored.

    A questionnaire evaluating quality and efficacy of pain management will be given to the patient before discharge. A telephone interview will be administered within 48 hours from discharge to assess for pain control, utilization of analgesics, and patient satisfaction



Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IV Acetaminophen
The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Drug: IV Acetaminophen
1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.
Other Name: OFIRMEV (Cadence Pharamceutical, San Diego, USA)
Placebo Comparator: Control
The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).
Drug: Placebo
100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.
Other Name: Normal Saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients undergoing surgical management for CRS (with or without polyps)
  2. Operating time must be at least 2 hours in duration.
  3. Number of sinuses involved must be 3 or greater

Exclusion criteria:

  1. History of hypersensitivity to acetaminophen
  2. End stage renal disease
  3. End stage liver disease
  4. History of chronic pain, or use of opioid medication in the previous two weeks
  5. Severe depression or anxiety
  6. Use of gabapentin or any other pain modulator
  7. History of acute sinusitis or mucocele
  8. History of seizures
  9. Known or suspected history of alcohol or drug abuse
  10. Known or suspected history of morphine intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608308

Contacts
Contact: Davide Cattano, MD, PhD (713) 500-6200 davide.cattano@uth.tmc.edu
Contact: Faramarz Ashoori, MD, PhD, DMS (713)500-6637 faramarz.ashoori@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Sciences Center at Houston Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Davide Cattano, MD, PhD         
Sub-Investigator: Amber Luong, MD, PhD         
Sub-Investigator: Martin J Citardi, MD         
Sub-Investigator: Samer Fakhri, MD         
Sub-Investigator: Matthew A Tyler, BA         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Cadence Pharmaceuticals
Investigators
Principal Investigator: Davide Cattano, MD, PhD The University of Texas Health Sciences Center at Houston
  More Information

No publications provided

Responsible Party: Davide Cattano, Associate Professor, Department of Anesthesia, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01608308     History of Changes
Other Study ID Numbers: HSC-MS-12-0111
Study First Received: May 25, 2012
Last Updated: December 12, 2013
Health Authority: United States: Federal Government
United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Chronic Sinusitis
Pain Relief
Post-Operative Opioid Requirement
IV Acetaminophen
Functional Endoscopic Sinus Surgery
FESS

Additional relevant MeSH terms:
Chronic Disease
Sinusitis
Disease Attributes
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Acetaminophen
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014