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Effect of Squeezable Bottle Nasal Irrigation Device in Children With Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02191046
First Posted: July 15, 2014
Last Update Posted: November 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
araya satdhabudha, Thammasat University
  Purpose
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

Condition Intervention
Sinusitis Device: squeezable bottle Device: syringe 20 ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized- Controlled Study Comparing the Effect of Squeezable Bottle Nasal Irrigation Device With Syringe in Children With Sinusitis

Resource links provided by NLM:


Further study details as provided by araya satdhabudha, Thammasat University:

Primary Outcome Measures:
  • the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children [ Time Frame: 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:
  • the Contamination in Nasal Irrigation Devices [ Time Frame: 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


Enrollment: 80
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: EEZNIS

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.
  Eligibility

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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191046


Locations
Thailand
Araya Satdhabudha
Klongluang, Pratumthanee, Thailand
Sponsors and Collaborators
Thammasat University
Investigators
Principal Investigator: Araya Satdhabudha, MD Thammasat University
  More Information

Responsible Party: araya satdhabudha, clinical professor, Thammasat University
ClinicalTrials.gov Identifier: NCT02191046     History of Changes
Other Study ID Numbers: ทป 45/2555
45/2555 ( Other Grant/Funding Number: Thammasat research grant )
First Submitted: July 13, 2014
First Posted: July 15, 2014
Results First Submitted: July 15, 2014
Results First Posted: November 4, 2014
Last Update Posted: November 4, 2014
Last Verified: October 2014

Keywords provided by araya satdhabudha, Thammasat University:
nasal irrigation
sinusitis
children
buffered hypertonic saline
nasal irrigation device

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases