Clinical trial NCT00465530
Conditions: Sinusitis
Sponsor: Julie Wei, MD
Start date: 2007-03-01; Completion date: 2010-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 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.

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 estimated 6-8 upper respiratory illnesses per year, usually viral, and only 13% are estimated to result in true sinusitis. True and chronic sinusitis, if not adequately treated, may result in long term symptoms including nasal airway obstruction, nasal congestion, persistent mucopurulent rhinorrhea, daytime and nocturnal cough, headaches, daytime fatigue, and even exacerbation or poor control of underlying asthma. A child's quality of life can be severely impacted as is their caretaker's due to days of missed school, frequency of doctor visits and courses of oral antibiotic therapy prescribed for the above mentioned symptoms, which ultimately result in the development of resistant organisms in addition to potential negative side effects associated with systemic oral antibiotic use.

Intranasal saline irrigation is underutilized in the pediatric population, most likely due to the presumption that children will not cooperate nor tolerate the act of irrigation. Saline irrigation of the nose is an inexpensive and generally well tolerated treatment with very little side effects or risks. Rigorous data regarding the efficacy of saline irrigation has become more available in this past decade, with most studies demonstrating a clear improvement in patient quality of life as measured by various study instruments or outcome surveys.

In our protocol, patients will be randomized to receive either saline alone or saline plus gentamycin in the solution form for nasal irrigation once daily for a six week treatment period. Weekly phone calls will be made to check for possible adverse events while patients are on treatment, and at the end of the treatment period another CAT scan will be performed to assess the status of the sinuses. Overall improvement will be determined based on the sinus status on the second CAT scan as well as the quality of life survey filled out by parents.

Arms: arm 1: Saline plus Gentamycin arm 2: Saline
Interventions: intervention 1: Saline intervention 2: Gentamycin
Intervention descriptions: intervention 1: Intranasal Saline intervention 2: Intranasal irrigation

Protocol documents: