Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Not Applicable

Completed

• Conditions: Sinusitis
• Interventions: Device: squeezable bottle; Device: syringe 20 ml

• Registration Number: NCT02191046
• Lead Sponsor: Thammasat University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-07-13
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-15
• Results First Submitted: 2014-07-15
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-31
• Last Update Submitted: 2014-10-31
• Results First Posted: 2014-11-04
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
squeezable bottle	squeezable bottle	nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
syringe 20 ml	syringe 20 ml	nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge

Primary Outcome Measures

Name	Time	Method
the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children	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	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

Secondary Outcome Measures

Name	Time	Method
the Contamination in Nasal Irrigation Devices	at second week after treatment	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

Trial Locations

Locations (1)

Araya Satdhabudha; 🇹🇭 Klongluang, Pratumthanee, Thailand