Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

NCT ID: NCT02191046

Last Updated: 2014-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-05-31

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.

Conditions

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Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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syringe 20 ml

nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge

Group Type ACTIVE_COMPARATOR

syringe 20 ml

Intervention Type DEVICE

nasal irrigation twice daily for 2 weeks

squeezable bottle

nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge

Group Type EXPERIMENTAL

squeezable bottle

Intervention Type DEVICE

nasal irrigation twice daily for 2 weeks period

Interventions

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squeezable bottle

nasal irrigation twice daily for 2 weeks period

Intervention Type DEVICE

syringe 20 ml

nasal irrigation twice daily for 2 weeks

Intervention Type DEVICE

Other Intervention Names

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EEZNIS

Eligibility Criteria

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Inclusion Criteria

1. age 3-15 years
2. 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

1. patient who has history of penicillin allergy
2. patient who has complication of sinusitis
3. patient with a history of nasal anatomical defects
4. patient who has immune deficiency or primary ciliary dyskinesia
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Thammasat University

OTHER

Sponsor Role lead

Responsible Party

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araya satdhabudha

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Araya Satdhabudha, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

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Araya Satdhabudha

Klongluang, Pratumthanee, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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45/2555

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

ทป 45/2555

Identifier Type: -

Identifier Source: org_study_id

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