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

Mahidol University

Status and phase: Unknown; Phase 4

Conditions: Rhinosinusitis

Treatments: Drug: Normal saline nasal irrigation; Drug: Gentamicin nasal irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02582099

271/2555(EC1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

1. Patients who used antibiotic prophylaxis within within 1 year before and 6 months after started gentamicin nasal irrigation
2. Patients received IVIG within 1 year before and 6 months after started gentamicin nasal irrigation
3. Patients received IT within 1 year before and 6 months after started gentamicin nasal irrigation
4. Patients underwent endoscopic sinus surgery within 1 year before and 6 months after started gentamicin nasal irrigation
5. Patient who have mental retardation
6. Patient who have aminoglycosides hypersensitivity reactions
7. Pregnancy women and Lactation period
8. Patient who have abnormal hearing test before started gentamicin nasal irrigation
9. Patient who have chronic rhinosinusitis with nasal polyp

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Gentamicin

Active Comparator group

Description:

Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Treatment:

Drug: Gentamicin nasal irrigation

Normal saline

Placebo Comparator group

Description:

Normal saline nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Treatment:

Drug: Normal saline nasal irrigation