Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191046
• Other study ID #: ?? 45/2555
• Secondary ID: 45/2555
• Status: Completed
• Phase: N/A
• First received: July 13, 2014
• Last updated: October 31, 2014
• Start date: March 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

Device:
• squeezable bottle
nasal irrigation twice daily for 2 weeks period
• syringe 20 ml
nasal irrigation twice daily for 2 weeks

Locations

Country	Name	City	State
Thailand	Araya Satdhabudha	Klongluang	Pratumthanee

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes