Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Study Overview
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Brief Summary
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The purpose of this study is to the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation

Detailed Description
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sinusitis is the one of common diseases in Thailand. Nasal irrigation has been used as an adjunctive treatment.In previous study shown that buffer hypertonic nasal irrigation have more effective to decrease symptom in patient sinonasal disease when compare to normal saline.Until now, there are no clear data comparing the effectiveness on sinonasal symptom of the various devices use in children with sinusitis. The purpose of this study was to compare the effect of squeezable bottle nasal irrigation device with syringe in children with sinusitis in symptom score and satisfaction to nasal irrigation.

Official Title
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A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis

Conditions
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Sinusitis

Intervention / Treatment
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* Device: squeezable bottle
* Device: syringe 20 ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 3-15 years diagnose sinusitis by each of following criteria 2.1 persistent upper respiratory infection symptoms > or = 10 days 2.2. severe upper respiratory infection symptom with greenish discharge per nose or periorbital swelling 2.3 double sickening of upper respiratory infection symptoms Exclusion Criteria: patient who has history of penicillin allergy patient who has complication of sinusitis patient with a history of nasal anatomical defects patient who has immune deficiency or primary ciliary dyskinesia

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: syringe 20 ml<br>nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge | Device: syringe 20 ml<br>* nasal irrigation twice daily for 2 weeks<br>|
| Experimental: squeezable bottle<br>nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge | Device: squeezable bottle<br>* nasal irrigation twice daily for 2 weeks period<br>* Other names: EEZNIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | For 5S-score, we measured the the mean 5-s score of both group at 2 weeks compare to the mean 5-s score at baseline visit and compare 5S-score between group at 2 weeks. The S5- score is a scale assessing severity of sinusitis. It compose of the symptom scores for nasal obstruction, day and nighttime cough, headache and nasal discharge. All symptom were graded from 0(no symptom) to 3 (severe ).The score were summed to give the mean 5S-score.It range from 0 (best possible outcome) to 15(worst possible outcome). 7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent). For satisfaction, we reported the result in the term of 7 points Likert scale and compare these scale between group at 2 weeks after treatment | compare 5S-score of both group at 2 week and at baseline visit .compare the mean 5S-score and satisfaction score between both group at 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Contamination in Nasal Irrigation Devices | compare the result of bacterial culture in both group of nasal irrigation devices. We reported in the following item; no growth, gram positive or gram negative or mixed organism | at second week after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal irrigation, sinusitis, children, buffered hypertonic saline, nasal irrigation device