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

This study has been completed.
Sponsor:
Collaborator:
Mallinckrodt
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: August 5, 2015
Last verified: August 2015
  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 when compared to a control group using the visual analogue score (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:
  • Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale [ Time Frame: 15 minutes and 120 minutes Post-Operatively ] [ Designated as safety issue: No ]
    VAS is a validated, self-reported data sheet assessing average pain intensity. Possible scores range from 0 (no pain) to 10 (highest level of pain).


Secondary Outcome Measures:
  • Total Doses of Postoperative Opiate (Morphine) Use [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) ] [ Designated as safety issue: No ]
    The total amount of morphine utilized in Postoperative Acute Care Unit (PACU) will be recorded. One dose is a 1mg bolus of morphine.

  • Number of Participants Who Received Intraoperative Supplemental Fentanyl [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) ] [ Designated as safety issue: No ]
    Number of participants who received intraoperative supplemental fentanyl. The decision to administer fentanyl is based on hemodynamic changes, such as increasing blood pressure and heart rate.

  • Number of Participants Who Experienced Postoperative Morbidity (Nausea) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery) ] [ Designated as safety issue: No ]
    Post-operative nausea will be monitored and measured through direct observation and nursing clinical record

  • Postoperative Vital Sign (Systolic Blood Pressure) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (1 hour after surgery) ] [ Designated as safety issue: No ]
    Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.

  • Postoperative Vital Sign (Diastolic Blood Pressure) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (1 hour after surgery) ] [ Designated as safety issue: No ]
    Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.

  • Postoperative Vital Sign (Pulse) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (1 hour after surgery) ] [ Designated as safety issue: No ]
    Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.

  • Postoperative Vital Sign (Temperature) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (1 hour after surgery) ] [ Designated as safety issue: No ]
    Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.

  • Postoperative Vital Sign (Respiratory Rate) [ Time Frame: During Postoperative Acute Care Unit (PACU) stay (1 hour after surgery) ] [ Designated as safety issue: No ]
    Postoperative vital signs (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate) were measured at different time points up to 4 hours after surgery.


Enrollment: 62
Study Start Date: July 2012
Study Completion Date: September 2014
Primary Completion Date: September 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

Locations
United States, Texas
The University of Texas Health Sciences Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Mallinckrodt
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
Results First Received: June 12, 2015
Last Updated: August 5, 2015
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 September 03, 2015