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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Gentamicin

Gentamicin nasal irrigation in chronic rhinosinusitis amount 20 ml each pernostril

Group Type ACTIVE_COMPARATOR

Gentamicin nasal irrigation

Intervention Type DRUG

Nasal wash with gentamicin solution

Normal saline

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

Group Type PLACEBO_COMPARATOR

Normal saline nasal irrigation

Intervention Type DRUG

Nasal wash with normal saline solution

Interventions

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Gentamicin nasal irrigation

Nasal wash with gentamicin solution

Intervention Type DRUG

Normal saline nasal irrigation

Nasal wash with normal saline solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes