Sinusitis
Conditions
Keywords
nasal irrigation, sinusitis, children, buffered hypertonic saline, nasal irrigation device
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.
Interventions
DEVICEsqueezable bottle
nasal irrigation twice daily for 2 weeks period
DEVICEsyringe 20 ml
nasal irrigation twice daily for 2 weeks
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 15 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Thailand
Participant flow
Recruitment details
we enrolled sinusitis patient age 3-15 year during March 2013 - May 2014. We excluded patients with a history of penicillin allergy, nasal anatomic defects, immunodeficiency or had complication from sinusitis. Patient with low compliance defined as the rate usage nasal irrigation estimated at less than 80% were excluded
Participants by arm
| Arm | Count |
|---|---|
| Syringe 20 ml nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge
syringe 20 ml: nasal irrigation twice daily for 2 weeks period | 36 |
| Squeezable Bottle nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge
squeezable bottle: nasal irrigation twice daily for 2 weeks period | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | low compliance | 5 | 1 |
Baseline characteristics
| Characteristic | Syringe 20 ml | Squeezable Bottle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 36 Participants | 38 Participants | 74 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Thailand | 36 participants | 38 participants | 74 participants |
| Sex: Female, Male Female | 11 Participants | 16 Participants | 27 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 36 | 7 / 38 |
| serious Total, serious adverse events | 0 / 36 | 0 / 38 |
Outcome results
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
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
Population: The S5- score is 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.7-point Likert scale for satisfaction score is scale from 1 (indicating unsatisfactory) to 7 (indicating excellent).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Syringe 20 ml | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | 5S-score at baseline | 6.56 units on a scale | Standard Deviation 2.35 |
| Syringe 20 ml | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | 5S-score at 2 weeks | 2.17 units on a scale | Standard Deviation 2.03 |
| Syringe 20 ml | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | satisfaction score at baseline | 5.11 units on a scale | Standard Deviation 1.19 |
| Syringe 20 ml | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | satisfaction score at 2 weeks | 6.11 units on a scale | Standard Deviation 0.85 |
| Squeezable Bottle | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | satisfaction score at 2 weeks | 6.57 units on a scale | Standard Deviation 0.64 |
| Squeezable Bottle | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | 5S-score at baseline | 6.89 units on a scale | Standard Deviation 2.49 |
| Squeezable Bottle | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | satisfaction score at baseline | 5.97 units on a scale | Standard Deviation 1.31 |
| Squeezable Bottle | the Effect of Squeezable Bottle and Syringe on Clinical Effectiveness in Sinusitis Children | 5S-score at 2 weeks | 1.24 units on a scale | Standard Deviation 1.55 |
Comparison: compare the mean 5S-score between before and after treatment in syringe groupp-value: <0.0595% CI: [3.41, 5.37]t-test, 2 sided
Comparison: compare the mean 5S-score between 2 groups at 2 weeks after treatmentp-value: <0.0595% CI: [0.094, 1.76]t-test, 2 sided
Comparison: satisfaction score between two groups at 2 weeks after treatmentp-value: <0.0595% CI: [-0.82, -0.12]t-test, 2 sided
Comparison: compare the mean 5s-score between before and after treatment in squeezable bottle groupp-value: <0.0595% CI: [4.62, 6.69]t-test, 2 sided
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
Time frame: at second week after treatment