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

NCT01608308 | Completed Results

• 1 other identifier: HSC-MS-12-0111
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Sinusitis

Keywords

Chronic Sinusitis; Pain Relief; Post-Operative Opioid Requirement; IV Acetaminophen; Functional Endoscopic Sinus Surgery; FESS

Outcome Measures

Primary Outcomes (1)

• Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale

  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).

  15 minutes and 120 minutes Post-Operatively

Secondary Outcomes (8)

• Total Doses of Postoperative Opiate (Morphine) Use

  During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

• Number of Participants Who Received Intraoperative Supplemental Fentanyl

  During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

• Number of Participants Who Experienced Postoperative Morbidity (Nausea)

  During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

• Postoperative Vital Sign (Systolic Blood Pressure)

  During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

• Postoperative Vital Sign (Diastolic Blood Pressure)

  During Postoperative Acute Care Unit (PACU) stay (up to 4 hours after surgery)

Study Arms (2)

IV Acetaminophen

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

IV Acetaminophen DRUG

1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.

Also known as: OFIRMEV (Cadence Pharamceutical, San Diego, USA)

IV Acetaminophen

Placebo DRUG

100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.

Also known as: Normal Saline

Control

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• History of hypersensitivity to acetaminophen
• End stage renal disease
• End stage liver disease
• History of chronic pain, or use of opioid medication in the previous two weeks
• Severe depression or anxiety
• Use of gabapentin or any other pain modulator
• History of acute sinusitis or mucocele
• History of seizures
• Known or suspected history of alcohol or drug abuse
• Known or suspected history of morphine intolerance

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mallinckrodt: collaborator

Study Sites (1)

The University of Texas Health Sciences Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Tyler MA, Lam K, Ashoori F, Cai C, Kain JJ, Fakhri S, Citardi MJ, Cattano D, Luong A. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Aug 1;143(8):788-794. doi: 10.1001/jamaoto.2017.0238.

  PMID: 28542675 DERIVED

MeSH Terms

Interventions

Acetaminophen; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Davide Cattano
• Organization: The University of Texas Health Science Center at Houston

Davide.Cattano@uth.tmc.edu

(713) 500-6200

Study Officials

• Davide Cattano, MD, PhD

  The University of Texas Health Sciences Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesia

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 31, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 16, 2015
• Results First Posted: September 4, 2015

Record last verified: 2015-09

Locations

US (1)