Trial · NCT00465530
Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
NCT00465530, Not applicable, Completed, Julie Wei, MD; results first posted 2013-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children. Trials, record NCT00465530. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00465530
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
- NCT number
- NCT00465530
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 40 participants, actual
- Lead sponsor
- Julie Wei, MD
- Conditions
- Sinusitis
- Interventions
- Saline, Gentamycin
- First posted
- 2007-04-25
- Last updated
- 2013-05-29
- Results first posted
- 2013-05-29
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Computed Tomography (CT) Score After Treatment | Change from Baseline to 6 Weeks | Change in CT score reflects the Lund-Mackay staging system. Each sinus is scored separately and scores are determined for the right and the left side. The lowest score of 0 represents no opacification in the sinus. A score of 1 represents a partial opacification. A score of 2 represents complete opacification. |
| Primary | Change in Overall Quality of Life | 3 Weeks to Follow-Up (7 Weeks) | Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem. |
| Secondary | Change in Overall Quality of Life | Baseline to 3 Weeks | Measured by Quality of Life Survey (SN-5). Scores ranged from 0 - 7. The higher the numerical score, the worse the problem. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Computed Tomography (CT) Score After Treatment | Change from Baseline to 6 Weeks | units on a scale | MEAN | |
| SECONDARY | Change in Overall Quality of Life | Baseline to 3 Weeks | units on a scale | MEAN | |
| PRIMARY | Change in Overall Quality of Life | 3 Weeks to Follow-Up (7 Weeks) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Computed Tomography (CT) Score After Treatment | Saline (Once Daily, 40 mL to Each Nostril) | Left maxillary | -.64 | Standard Deviation .63 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril) | Left maxillary | -.63 | Standard Deviation .5 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline (Once Daily, 40 mL to Each Nostril) | Right maxillary | -.5 | Standard Deviation .65 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril) | Right maxillary | -.5 | Standard Deviation .63 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline (Once Daily, 40 mL to Each Nostril) | Left anterior ethmoid | -.79 | Standard Deviation .7 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril) | Left anterior ethmoid | -1.06 | Standard Deviation .68 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline (Once Daily, 40 mL to Each Nostril) | Right anterior ethmoid | -.79 | Standard Deviation .8 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril) | Right anterior ethmoid | -.63 | Standard Deviation .81 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline (Once Daily, 40 mL to Each Nostril) | Left posterior ethmoid | -.57 | Standard Deviation .65 | units on a scale |
| Change in Computed Tomography (CT) Score After Treatment | Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril) | Left posterior ethmoid | -.81 | Standard Deviation .66 | units on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 21 | |
| Overall Study | STARTED | Saline (Once Daily, 40 mL to Each Nostril) | 19 | |
| Overall Study | COMPLETED | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 19 | |
| Overall Study | COMPLETED | Saline (Once Daily, 40 mL to Each Nostril) | 15 | |
| Overall Study | NOT COMPLETED | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 2 | |
| Overall Study | NOT COMPLETED | Saline (Once Daily, 40 mL to Each Nostril) | 4 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Otalgia | Ear and labyrinth disorders | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 0 | 21 | 0 |
| other | Otalgia | Ear and labyrinth disorders | Saline (Once Daily, 40 mL to Each Nostril) | 1 | 19 | 3 |
| other | Symptoms of Allergic rhinitis | General disorders | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 1 | 21 | 1 |
| other | Symptoms of Allergic rhinitis | General disorders | Saline (Once Daily, 40 mL to Each Nostril) | 1 | 19 | 1 |
| other | Acute otitis media (AOM) | General disorders | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 0 | 21 | 0 |
| other | Acute otitis media (AOM) | General disorders | Saline (Once Daily, 40 mL to Each Nostril) | 2 | 19 | 2 |
| other | Epistaxis | Ear and labyrinth disorders | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 1 | 21 | 1 |
| other | Epistaxis | Ear and labyrinth disorders | Saline (Once Daily, 40 mL to Each Nostril) | 0 | 19 | 0 |
| other | Cough | General disorders | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 1 | 21 | 1 |
| other | Cough | General disorders | Saline (Once Daily, 40 mL to Each Nostril) | 0 | 19 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | ||
| Total, all-cause mortality | Saline (Once Daily, 40 mL to Each Nostril) | ||
| Total, other adverse events | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 3 | 21 |
| Total, other adverse events | Saline (Once Daily, 40 mL to Each Nostril) | 6 | 19 |
| Total, serious adverse events | Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) | 0 | 21 |
| Total, serious adverse events | Saline (Once Daily, 40 mL to Each Nostril) | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril) vs Saline (Once Daily, 40 mL to Each Nostril): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00465530
GET https://conductscience.org/api/trials/v1/NCT00465530/results?page=2