Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Thammasat University

Status: Completed

Conditions: Sinusitis

Treatments: Device: syringe 20 ml; Device: squeezable bottle

Study type: Interventional

Funder types: Other

Identifiers

NCT02191046

45/2555 (Other Grant/Funding Number)

ทป 45/2555

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

syringe 20 ml

Active Comparator group

Description:

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

Treatment:

Device: syringe 20 ml

squeezable bottle

Experimental group

Description:

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

Treatment:

Device: squeezable bottle