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Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children

NCT00465530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-05-29

Study results available
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Summary

Healthy children may develop symptoms of chronic sinusitis such as chronic cough, chronic runny nose, nasal congestion, even headaches. Such symptoms may persist long after the child gets over other symptoms of a cold and commonly result in the prescription of oral antibiotics. The purpose of this study is to evaluate whether using saline alone or saline plus an antibiotic (gentamycin) to irrigate the nose directly once a day for 6 weeks is effective and safe for the treatment of the above named symptoms. Computerized axial tomography (CAT) scans and quality of life surveys will be used to compare the health of the sinuses before and after treatment, and scored to determine which of the two treatments, saline alone or saline with gentamycin, is more effective in the treatment of this condition. The study hypothesis is that intranasal saline irrigation will work as well as saline plus gentamycin, and that majority of the patients will experience significant improvement after a 6 week treatment period.

Conditions

  • Sinusitis

Interventions

DRUG

Saline

Intranasal Saline

DRUG

Gentamycin

Intranasal irrigation

Sponsors & Collaborators

  • Julie Wei, MD

    lead OTHER

Principal Investigators

  • Julie L Wei, M.D. · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00465530 on ClinicalTrials.gov