Status:
COMPLETED
Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
Lead Sponsor:
Julie Wei, MD
Conditions:
Sinusitis
Eligibility:
All Genders
4-17 years
Phase:
NA
Brief 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 s...
Detailed Description
In the pediatric population, rhinosinusitis is a common concern resulting frequently in the frequent and unsuccessful prescription of systemic oral antibiotic therapy. Children typically experience an...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00465530
Start Date
March 1 2007
End Date
March 1 2010
Last Update
May 29 2013
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
University of Kansas MedWest
Shawnee, Kansas, United States, 66217