Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

NCT02191046 | Completed Results

• 2 other identifiers: ทป 45/255545/2555
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Sinusitis

Keywords

nasal irrigation; sinusitis; children; buffered hypertonic saline; nasal irrigation device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• the Contamination in Nasal Irrigation Devices

  at second week after treatment

Study Arms (2)

syringe 20 ml

ACTIVE COMPARATOR

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

Device: syringe 20 ml

squeezable bottle

EXPERIMENTAL

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

Device: squeezable bottle

Interventions

squeezable bottle DEVICE

nasal irrigation twice daily for 2 weeks period

Also known as: EEZNIS

squeezable bottle

syringe 20 ml DEVICE

nasal irrigation twice daily for 2 weeks

syringe 20 ml

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 3-15 years
• 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

You may not qualify if:

• patient who has history of penicillin allergy
• patient who has complication of sinusitis
• patient with a history of nasal anatomical defects
• patient who has immune deficiency or primary ciliary dyskinesia

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Araya Satdhabudha

Klongluang, Pratumthanee, Thailand

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Syringes

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

• Title: Dr.Araya Satdhabudha
• Organization: Thammasat university

araya221@gmail.com

0813414900

Study Officials

• Araya Satdhabudha, MD

  Thammasat University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 15, 2014
• Study Start: March 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 4, 2014
• Results First Posted: November 4, 2014

Record last verified: 2014-10

Locations

TH (1)