Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery
Condition: Chronic Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

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.
    

Detailed description: 
      Unrelieved postoperative pain may result not only in suffering and discomfort, but may also
      lead to multiple physiological and psychological consequences which can contribute to adverse
      perioperative outcomes. Inadequate perioperative analgesia can potentially contribute to a
      higher incidence of myocardial ischemia. Additionally, the use of opioids has been associated
      with major side effects that can include impaired wound healing and delayed gastrointestinal
      (GI) motility that results in prolonged postoperative ileus.

      Intravenous acetyl-para-aminophenol (APAP, also known as acetaminophen) is considered as the
      non-opioid analgesic of choice to treat postoperative mild and moderate pain, and has been
      demonstrated in several randomized trials to be both safe and effective at reducing acute
      post-operative pain in both children and adults. Furthermore, in the treatment of severe
      pain, it can reduce the need for opioid-analgesics while exhibiting a relatively limited side
      effect profile when compared to opioids and nonsteroidal anti-inflammatory drugs.

      Chronic rhinosinusitis (CRS) describes a group of disorders characterized by inflammation of
      the nasal mucosa and/or paranasal sinuses for at least 12 consecutive weeks. In the United
      States, CRS affects approximately 30 million people, and represents 2% of the primary
      diagnoses in physician office visits, resulting in an estimated 200,000 sinus procedures
      annually. Patients suffering from CRS that is refractory to medical management complain of
      symptoms that include fatigue, headache, nasal drainage, facial pain and pressure, and
      decreased sense of smell. Functional endoscopic sinus surgery (FESS) represents a surgical
      approach to treating CRS that is unresponsive to medical management. Outcomes studies have
      identified FESS as efficacious at reducing the majority of symptoms related to CRS. Despite
      this, pain associated with CRS remains a significant co-morbidity that often is resistant to
      both medical and surgical management. Reducing the incidence and severity of acute
      post-operative pain is paramount to reducing the development of chronic pain that may
      exacerbate a patient's existing pain. The use of pre- and intra- operative IV acetaminophen
      thus serves as a unique pain management modality in this setting, as it has the potential for
      reducing post-operative complications and pain, with the additional benefit of minimal
      intraoperative bleeding, an undesirable complication often associated with FESS and with the
      use of non-steroidal anti-inflammatory drugs (NSAIDs).

      The use of IV acetaminophen in ear, nose, and throat (ENT) surgery is not a novel endeavor.
      Indeed, studies have demonstrated the efficacy and safety of IV acetaminophen for use in
      tonsillectomy and FESS. We wish to provide a more comprehensive analysis of pain management
      in the setting of FESS in the following ways :

        1. by administering IV acetaminophen perioperatively (before start of surgery, and after
           surgery completion;

        2. by employing a pain score of 4 (whereas other studies use 3) as a cutoff for
           breakthrough pain; and,

        3. by addressing novel outcomes including patient sedation and patient satisfaction, in
           addition to opioid analgesic use.

      In our institution, we have completed a preliminary pilot study exploring the use of
      intravenous anesthesia which included acetaminophen during bilateral endoscopic sinus
      surgery. Secondary outcomes measured during the study included:

        1. Pain

        2. Rescue analgesic use

        3. Nausea/Vomiting

        4. Time spent in recovery

        5. Successful discharge from the PACU and the Hospital

      Our pilot data has reaffirmed that the procedure is overall benign, with few associated risks
      and adverse events. Of note, none of the patients in our preliminary study required admission
      to the hospital after surgery for further observation as a result of uncontrolled pain or
      nausea. Based on this experience, we would like to explore the efficacy of intravenous
      acetaminophen (Ofirmev), a non opioid/non steroidal analgesic, in endoscopic sinus surgery.
    

Intervention name(s): IV Acetaminophen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.; 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.
Other intervention name(s): OFIRMEV (Cadence Pharamceutical, San Diego, USA); Normal Saline
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chronic Sinusitis; Pain Relief; Post-Operative Opioid Requirement; IV Acetaminophen; Functional Endoscopic Sinus Surgery; FESS