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Clinical Standard for Sinusitis Management

Core Document

TITLE: MADIGAN ARMY MEDICAL CENTER CLINICAL STANDARD FOR SINUSITIS MANAGEMENT 

INDICATIONS FOR THE CLINICAL STANDARD:  Sinusitis affects an estimated 35 million Americans each year.  Its prevalence is estimated to be 5-15% in adults and up to 5% in children.  It is increasing in prevalence in all age groups and accounted for nearly 25 million office visits in the United States in 1993 and 1994.  It was the fifth most common diagnosis for which an antibiotic was prescribed.  Antibiotic prescriptions for sinusitis rose from 5.8 million in 1985 to 13 million in 1992.  The direct medical cost of sinusitis in 1992 was $2.4 billion.  Ideal management includes administration of preventive measures as well as the application of proper baseline medical therapy in adequate dosages and duration.  It is important for the primary care physician to know the factors associated with the diagnosis of chronic rhinosinusitis and properly diagnose acute, chronic, recurrent sinusitis.

METRICS:  THE KEY ELEMENTS OF THE CLINICAL STANDARD THAT WILL BE USED TO MONITOR PROVIDER ADHERENCE TO THE CLINICAL STANDARD:  
1. Documented history of 2 major symptoms (face pain-pressure, facial congestion-fullness, nasal obstruction-blockage, nasal discharge-purulence-discolored postnasal drip, hyposmia-anosia) or 1 major symptom and 2 minor symptoms (fever-chronic, halitosis, fatigue, dental pain, cough, and ear pain-pressure-fullness), or nasal purulence on examination.
2. Documented first line antibiotic therapy (Pharmacy Antibiogram, Sinusitis Practice Recommendation  below) with appropriate decongestant therapy for a minimum of 7 days beyond the last symptom of facial pain or purulent rhinorrhea.  Include antihistamines and nasal steroids if a history of allergy is present.
3. Documented repeat first line therapy or second line antibiotic (refer to Pharmacy Antibiogram) and with appropriate decongestant therapy for a minimum of 7 days beyond the last symptom of facial pain or purulent rhinorrhea.  Again include antihistamines and nasal steroids if a history of allergy is present.
4. Documentation that all cases, which fail antibiotic therapy, requiring referral (Referral Guidelines) to ENT or Allergy must have an abnormal sinus CT scan.  Abnormal paranasal sinus Coronal CT scan without contrast is defined as having air-fluid levels, or mucosal thickening > 2mm, or sinus opacification or obstructive or neoplastic pathology or complicated sinusitis – extension of disease beyond the sinuses (i.e., meningitis, CNS empyema, brain abscess, cavernous sinus thrombosis, osteomyelitis, and periorbital infections).

DATE: Published:  May 1998, Revised:  September 1999, April 2002.

AUTHORS
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AREAS OF DISAGREEMENT:  There are no major areas of disagreement, however antibiotic resistance is a growing concern.  The medical practitioner should first, prescribe and teach prevention considering decongestants (topical and systemic) and/or antihistamines as the first line of therapy, and second understand the sign and symptoms of sinusitis before prescribing antibiotics.[1]  The length of antibiotic therapy is also controversial, we feel that because infected sinus fluids are extracellular they require a minimum of ten days of therapy or at least 3 days beyond the last symptoms.[2]  Choice of antibiotics should be selected from culture-proven bacterial sinusitis, however in most cases cultures are difficult to obtain and hospital antibiograms (Pharmacy Antibiogram) are often used successfully in their place.  Costs of antibiotic therapy is a major consideration however, second line therapy is becoming more reasonable, and may be better value in light of antibiotic resistance in first line therapy, these medications will become important for refractory and atypical cases [3].  Signs and symptoms of acute and chronic sinusitis have not been standardized and have been an area of disagreement.  A sinus task force recently outlined the factors associated with sinusitis to establish "standard" definitions and guidelines to help guide the practitioner to improve the treatment of sinusitis.[4]

PUBLISHED STANDARDS OF CARE AND OTHER REFERENCES UPON WHICH THE CLINICAL STANDARD IS BASED:  
1. Gross CW, Becker DG, et al: Advances in sinus and Nasal Surgery, The Otolaryngology Clinics of North America, June 1997
2. Williams: Randomized Controlled Trial of 3 vs. 10 Days of Trimethoprim-
Sulfamethoxazole for Acute Maxillary sinusitis, JAMA, April 5, 1995-vol 273, No.13
3. MAMC Pharmacy Guidelines: Oral antibiotic Guidelines: Sinusitis (Adults), 1998
4. Lanza DC, Kennedy DW, et al. Adult Rhinosinusitis Defined. Report of the
Rhinosinusitis Task Force Committee Meeting. Otolaryngology-Head and Neck
Surgery 1997; 117; S4-S5
5. Senior BA, Kennedy DW: Long-term Results of Functional Endoscopic Sinus
Surgery. Laryngoscope 1998 Feb:108(2):151-7
6. OTG-D7 sinusitis ICD-9: 461.X, 473.X. Ear Nose and Throat Conditions, Chapter II
7. OTG’s for Common Conditions Usually Treated in an Ambulatory Setting, Healthcare Management Guidelines, Milliman & Robertson, Inc., November 1997
8. ISP: Otolaryngology, Dental & Oro-Maxillo-Facial Surgery (OS 64-69), Inter Qual, Inc. 1995
9. Pankey GA, Gross DW, Mendelsohn MG:  Contemporary Diagnosis and Management of Sinusitis, 3rd ed, 2000 by Handbooks in Health Care Co, Pennsylvania 18940 (www.HHCbooks.com)

CLINICAL PRACTICE RECOMMENDATIONS:

1. Diagnosis of Sinusitis = 2+ Major or 1 Major + 2 Minor or Nasal Purulence on examination.
Major Factors
Face pain-pressure 
Facial congestion-fullness 
Nasal obstruction-blockage
Nasal discharge - purulence-discolored postnasal drip
Hyposomia-anosia 
Minor Factors:
Fever - chronic
Halitosis
Fatigue
Dental pain,
Cough
Ear pain-pressure

2. Acute Sinusitis (Adult) (Pathway) - Diagnosis: Acute sinusitis must be differentiated from viral URI that improves in 5-10 days; bacterial sinusitis worsens and has a duration of < 4 weeks to be considered acute. To diagnose and treat with antibiotics a strong history of 2 or more major factors, or 1 major factor and 2 minor factors or nasal purulence on examination.  Medical therapy includes antibiotics, decongestants, mucolytics, steroids and analgesics discussed below.

Acute Sinusitis - Common Pathogens (Pathway): Streptococcus pneumonia, Haemophilus influenza, and Moraxella catarrhalis. Occasionally Group A Streptococci are isolated from children, as is Staphylococcus aureus from adults. There is no evidence that atypical pathogens (e.g., Mycoplasma, Chlamydia) have any significant role in sinusitis.

Acute Sinusitis - Medical Treatment (Pathway): Nasal saline rinses (1 pint water + 1/2 tsp.  Salt and 1/4 tsp. baking soda) several times a day reduces mucosal swelling and clears secretions. Topical decongestants, phenylephrine nose drops for children or oxymetazoline HCL (Afrin) nose spray for adults bid for 3-4 days only to promote drainage.  Supplement with systemic decongestants if not hypertensive, pseudoephedrine 30-60mg po bid.  Consider mucolytics like guaifenesin (Humabid) 600-1200mg po bid to thin secretions and reduce coughing.  Analgesics are added for pain, and steroids are indicated for nasal polyposis that is complicating the disease process.  Use antihistamines only if underlying allergic disease is present.

Acute Sinusitis: Antibiotic Therapy (use after viral URI is ruled out) (Pharmacy Antibiogram)

First Line: mild symptoms, for the common organisms treat for 2-3 weeks  (** used for but not approved by the FDA for acute bacterial sinusitis).
a.  amoxicillin trihydrate (generic)** 500mg q 8 hours or 875mg q12h for 14-21 days
b.  doxycycline (generic)** 100mg po q 12 hours for 14-21 days (avoid in children)
c.  trimethoprim/sulfamethoxazole DS (generic)** 160/800 mg q 12 hours for 14-21 days for patients allergic to penicillin (avoid in pregnancy)

Second Line: (for initial treatment failure, consider Streptococcus pneumonia resistance or a B-lactamase resistance).  See current guidelines (Pharmacy Antibiogram) for availability.  Culture directed antibiotics are the procedure of choice but they are often difficult to do in clinical settings, antibiogram (Pharmacy Antibiogram) for local hospital resistance is second choice. Second Line [9]: Consideration for 14-28 days of antibiotics should be considered, individual medications may vary, please read manufacture guidelines for sinusitis. (*approved by the FDA 2000 for bacterial sinusitis in adults, **used but not approved)
a.  azithromycin (ZithromaxTM)** 500mg, then 25mg x 4 days, repeat in 10 days (used but not approved for sinusitis)
b.  amoxicillin-clavulanate (AugmentinTM)* 500/125 mg q8h or 875/125 mg q12h 14-28 days.  (b-lactamase-producing strains of H. influenzae, M. catarrhalis)
c.  cefdinir (OmnicefTM)* 600 mg qd 14-28 days (S. pneumonia, b-lactamase-producing strains of H. influenzae, M. catarrhalis)
d.  cefprozil (CefzilTM)* 250-500 mg bid 14-28 days (S. pneumonia, b-lactamase-producing strains of H. influenzae, M. catarrhalis)
e.  cefuroxime axetil (CeftinTM)* 250mg po bid for 14-28 days (NON b-lactamase-producing strains of H. influenzae,  S. pneumoniae)
f.  ciprofloxacin HCL (CiproTM)* 500mg bid 14-28 days (adults) (S. pneumoniae, H. influenzae, M. catarrhalis)
g.  clarithromycin (BiaxinTM)* 500mg po bid for 14-28 days (S. pneumoniae, H. influenzae, M. catarrhalis)
h.  levofloxacin (LevaquinTM)* 500 mg qd 14-28 days (S. pneumoniae, H. influenzae, M. catarrhalis)
i.  moxifloxacin (AveloxTM)* 400mg qd 14-28 days (S. pneumoniae, H. influenzae, M. catarrhalis)

Third Line: (persistent-unresponsive to the above, consider anaerobic org.)
a.  clindamycin HCL (Cleocin) 150mg qid for 14-21 days (clindamycin has no H influenzae or M catarrhalis activity).

3. Chronic Sinusitis (Adult): By definition this condition is >12 weeks with the same factors as above, usually bacteria role is minimal, opportunistic anaerobic organisms colonize, etiology is chronic obstruction from allergies, chronic mucosal disease, polyposis, cystic fibrosis, neutropenia or immunological compromise (pseudomonas aeruginosa, mycobacteria, aspergillosis, cytomegalovirus).  Often anatomic abnormalities exist, septal obstruction, osteomeatal scarring, contact point pain, odontogenic (dental) infections, or mucociliary dysfunction.  Surgery improves these symptoms in 98% of the cases over the long term.[5]

4. Recurrent Sinusitis (Adult): > 4 episodes per year with each lasting 7-10 days and absence of chronic rhinosinusitis.

5. Acute Sinusitis (Pediatric): Starts as a complication to viral URI, obstructive, purulent rhinorrhea with fever, lasting longer than 10 days. Same acute organisms as adult.  Treat if symptoms persist after 14 days, use nasal saline irrigation and decongestant with 2 weeks of antibiotics.  For second line consider Amoxicillin-Augmentin combination to achieve 80 mg/kg/day total of the Amoxicillin with ½ being Augmentin to cover beta lactamase producers and resistant Streptococcus pneumonia.  Refer to pediatric dosages; flouroquinolones are not appropriate for pediatric use.

6. Chronic Sinusitis (Pediatric): purulent rhinorrhea, daytime cough, worse at night emesis from coughing fits, nasal obstruction, headaches, rare fever.  Organisms are also alpha-hemolytic strep and staphylococcus and can contain anaerobes.  Chronic sinusitis work up includes an allergy-immunology work up, sweat testing for cystic fibrosis, tobacco exposure history, and esophageal reflux evaluation.  Radiology is not necessary unless failed maximal medical therapy or has a complication of sinusitis.  Antibiotic treatment is second line for 6 weeks), to include nasal steroids and saline irrigation, and should be offered a yearly influenza vaccine.  Disease is generally self-limiting, and rarely is surgery required.  CT scan is required for persistent disease after prolonged maximal therapy.  ENT referral is considered for evaluation for intense medical management, adenoidectomy and/or limited functional endoscopic sinus surgery.

7. Clinical Indications for Imaging
 -Acute Sinusitis: None required unless primary therapy fails.
-Chronic Sinusitis: Coronal CT Sinuses without contrast for medically refractory symptoms (unsuccessful 12-week course of antibiotics), recurrent sinusitis (>4 per year). For complicated sinusitis (i.e., meningitis, CNS empyema, brain abscess, cavernous sinus thrombosis, osteomyelitis, and periorbital infections).  For cases requiring ENT referral.

8. Surgical referral (ENT Guidelines) : For (1) chronic sinusitis (after aggressive medical therapy-decongestant spray, systemic decongestants, 12 weeks of antibiotics, include antihistamines and nasal steroids if a history of allergy is present) or recurrent sinusitis (>4 per year with appropriate therapy as above) or paranasal sinus (2)Coronal CT scan without contrast demonstrating air-fluid levels, or mucosal thickening > 2mm, or sinus opacification or obstructive or neoplastic pathology or complicated sinusitis (i.e., meningitis, CNS empyema, brain abscess, cavernous sinus thrombosis, osteomyelitis, and periorbital infections. 3) Immune defects (IG2 and IgA) not responsive to medical therapy, 4) refractory sinusitis complicating chronic pulmonary disease (asthma, cystic fibrosis, triad asthma, etc.) and 5) persistent headache, nasal polyposis, or anosmia. All cases requiring ENT referral or other subspecialty referral should have a CT scan first.

9. Allergy referral: Prior to referral to allergy clinic, patients with chronic or frequent recurrent sinusitis should be evaluated with CT scan of the sinuses to rule out a structural problem.  They should also be treated with a 4-week course of nasal steroids in conjunction with the other medical therapy as noted above.  If that is ineffective, sinusitis secondary to allergic rhinitis can often be improved by immunotherapy (allergy shots) and/or changes in the patient's environment once allergic triggers are known.  They should be considered for RAST or referral to allergy clinic.  If the patient has been found to be nonallergic, they do not need to be referred to the allergy clinic again unless a new problem has developed.

KEY POINTS:

1.  Identify the patient with clinical signs and symptoms consistent with acute, recurrent acute, or chronic sinusitis.
2.  Recognize sinusitis is a potentially debilitating problem that requires precise diagnosis and prompt, effective treatment.
3.  Formulate a management plan based on what is now known as the pathophysiology of sinusitis, with special attention to the role of obstruction of the ostia and ostiomeatal complex (OMC).
4.  Use a protocol for first-line medical management of acute sinusitis that includes antibiotics and decongestants as baseline therapy.
5.  Understand that antihistamines are indicated primarily to treat patients in whom predisposing allergic factors (release of histamines) are present.
6.  Predict the failure of plain x-ray films to yield conclusive information about the OMC in acute sinusitis.
7.  Select those patients with sinusitis who may need further evaluation by computed tomography (CT), and appropriate referral for specialized care.

IMPACT STATEMENT TO INSTITUTION: The treatment of sinusitis occurs through Madigan Army Medical Center the surrounding military medical centers in all the primary care portals, troop medical clinics, pediatric clinics, allergy-immunology services and otolaryngology services.

LINKS WITHIN THE MAMC INTRANET: Hot link in the MAMC Intranet - Other links within the topic are the pharmacy guidelines, referral guidelines and the hospital antibiogram, enabling clinicians to review the antimicrobial resistance for our community and adjust second line antibiotic therapy without requiring cultures.

METHODS OF PROVIDER EDUCATION: Provider education by CME classes, Intranet accesses, referral guideline menus, pocket guides, clinic copies of clinical standards with hospital briefings.

METHODS OF PATIENT EDUCATION:  Sinusitis Guidelines for the Patient (drawing credit, Krames Health and Safety Education).

REVISION FREQUENCY: This standard will be reviewed by the POC and presented to the Clinical Standards Committee annually or sooner if needed.  Hotlinks to data sites like the pharmacy guidelines, referral guidelines, and the antibiogram would refresh and give up-to-date data on a regular basis.  Additions from the portal and specialty areas can be added as needed.



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