Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

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

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

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Device: syringe 20 ml; Device: squeezable bottle

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Pratumthanee
    • Klongluang, Pratumthanee, Thailand
      • Araya Satdhabudha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Thammasat University
• Investigators: Principal Investigator: Araya Satdhabudha, MD, Thammasat University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 13, 2014
• First Submitted That Met QC Criteria: July 14, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 4, 2014
• Last Update Submitted That Met QC Criteria: October 31, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: children; nasal irrigation; sinusitis; buffered hypertonic saline; nasal irrigation device
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: ทป 45/2555; 45/2555 (Other Grant/Funding Number: Thammasat research grant)