The Efficacy and Complication of Gentamicin Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis

Study Overview
=================
Brief Summary
-----------------
Topical antibiotic therapy in patients with refractory sinusitis has been shown to improve symptoms, quality of life, and mucosal aspect. In pediatrics allergy clinic at Siriraj hospital since 2006 use Gentamicin nasal irrigation for chronic rhinosinusitis.There have been no prospective studies in gentamicin irrigation in chronic rhinosinusitis.

Detailed Description
-----------------
Chronic rhinosinusitis (CRS) is characterized by symptoms > 12 weeks.Two or more symptoms one of which should be either nasal blockage /obstruction/congestion or nasal discharge (anterior/posterior nasal drip): facial pain/pressure reduction or loss of smell). Mainstay of treatment are medical and surgical treatment ( ATB, adenoidectomy, ESS) Adjunctive treatment : normal saline nasal irrigation, nasal corticosteroids, nasal decongestants, mucolytics. Nasal lavage with Mupirocin represent an effective and well tolerated alternative treatment of surgically recalcitrant chronic rhinosinusitis. Gentamicin irrigation should be helpful in chronic rhinosinusitis.

Official Title
-----------------
Comparison of the Efficacy and Complication of Gentamicin and Normal Saline Nasal Irrigation in Chronic Rhinosinusitis and Recurrent Sinusitis : a Double Blind Randomized Control Trial

Conditions
-----------------
Rhinosinusitis

Intervention / Treatment
-----------------
* Drug: Gentamicin nasal irrigation
* Drug: Normal saline nasal irrigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Chronic rhinosinusitis and/or recurrent acute/subacute sinusitis patients who were followed in pediatrics allergy clinic at Siriraj hospital between December 4, 2012, and December 3, 2016 Exclusion Criteria: Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation Patient who have mental retardation Patient who have aminoglycosides hypersensitivity reactions Pregnancy women and Lactation period Patient who have abnormal hearing test before started gentamicin nasal irrigation Patient who have chronic rhinosinusitis with nasal polyp

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gentamicin<br>Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril | Drug: Gentamicin nasal irrigation<br>* Nasal wash with gentamicin solution<br>|
| Placebo Comparator: Normal saline<br>Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril | Drug: Normal saline nasal irrigation<br>* Nasal wash with normal saline solution<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of sinusitis |  | During 1 year after treatment |