Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. The purpose of this study is to evaluate whether using saline alone or saline plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is effective and safe for the treatment of the above named symptoms. Computerized axial tomography (CAT) scans and quality of life surveys will be used to compare the health of the sinuses before and after treatment, and scored to determine which of the two treatments, saline alone or saline with gentamycin, is more effective in the treatment of this condition. The study hypothesis is that intranasal saline irrigation will work as well as saline plus gentamycin, and that majority of the patients will experience significant improvement after a 6 week treatment period.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Julie Wei, MD
• Treatments: Gentamicins

Criteria

Inclusion Criteria:

• Healthy children age 4-17

• History of "Recurrent" or "Chronic Sinusitis"

• Definition: History must include > 3 months of any or a combination of the following symptoms:

• Nasal congestion/nasal airway obstruction

• Rhinorrhea/Nasal discharge

• Persistent cough (daytime)

• Postnasal drip

• Headache

• Facial pain

• Foul breath

• Intermittent fever

• Caregiver (proxy responsible) able to read and understand English

• Has had at least 3 courses or a total of 21 days of oral antibiotic therapy for above symptoms in the previous 3 months

• Child has a CT scan of the coronal sinus without contrast within two months prior to visit date, which demonstrates and opacification of a single or multiple, ipsilateral or bilateral sinuses.

Exclusion Criteria:

• Inability of caregiver to read and understand English

• Mental retardation, cognitive impairment, or developmental delay

• History of cystic fibrosis

• History of immotile cilia syndrome

• History of immune suppression/immune compromise

• CT scan within past 4 weeks available for review at time of clinic visit which is entirely negative for evidence of sinus disease plus complete absence of any of the above symptoms

• History of endoscopic sinus surgery

• History of patient's inability to tolerate attempted nasal irrigation in the past 6 months

• History of recent use of gentamycin intranasal irrigation or saline irrigation within the past 3 months

• History of presence of nasal polyposis

• History of allergic reaction of any kind to intravenous gentamycin or aminoglycosides in past medical history (for treatment of any infections)