Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery (IVAPAP)
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.
|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|
- 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.
- 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
|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)|
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).
100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.
Other Name: Normal Saline
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01608308
|Contact: Davide Cattano, MD, PhD||(713) firstname.lastname@example.org|
|Contact: Faramarz Ashoori, MD, PhD, DMS||(713)email@example.com|
|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|
|Principal Investigator:||Davide Cattano, MD, PhD||The University of Texas Health Sciences Center at Houston|