Comparing the Use of Saline or Saline Plus Gentamycin in Nasal Irrigation to Treat Chronic Sinusitis in Children
Safety and Efficacy of Once Daily Intranasal Gentamycin Irrigation Versus Saline in the Treatment of Pediatric Chronic Sinusitis
調査の概要
詳細な説明
In the pediatric population, rhinosinusitis is a common concern resulting frequently in the frequent and unsuccessful prescription of systemic oral antibiotic therapy. Children typically experience an estimated 6-8 upper respiratory illnesses per year, usually viral, and only 13% are estimated to result in true sinusitis. True and chronic sinusitis, if not adequately treated, may result in long term symptoms including nasal airway obstruction, nasal congestion, persistent mucopurulent rhinorrhea, daytime and nocturnal cough, headaches, daytime fatigue, and even exacerbation or poor control of underlying asthma. A child's quality of life can be severely impacted as is their caretaker's due to days of missed school, frequency of doctor visits and courses of oral antibiotic therapy prescribed for the above mentioned symptoms, which ultimately result in the development of resistant organisms in addition to potential negative side effects associated with systemic oral antibiotic use.
Intranasal saline irrigation is underutilized in the pediatric population, most likely due to the presumption that children will not cooperate nor tolerate the act of irrigation. Saline irrigation of the nose is an inexpensive and generally well tolerated treatment with very little side effects or risks. Rigorous data regarding the efficacy of saline irrigation has become more available in this past decade, with most studies demonstrating a clear improvement in patient quality of life as measured by various study instruments or outcome surveys.
In our protocol, patients will be randomized to receive either saline alone or saline plus gentamycin in the solution form for nasal irrigation once daily for a six week treatment period. Weekly phone calls will be made to check for possible adverse events while patients are on treatment, and at the end of the treatment period another CAT scan will be performed to assess the status of the sinuses. Overall improvement will be determined based on the sinus status on the second CAT scan as well as the quality of life survey filled out by parents.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kansas
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Kansas City、Kansas、アメリカ、66160
- University of Kansas Medical Center
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Shawnee、Kansas、アメリカ、66217
- University of Kansas MedWest
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Healthy children age 4-17
History of "Recurrent" or "Chronic Sinusitis"
- Definition: History must include > 3 months of any or a combination of the following symptoms:
- Nasal congestion/nasal airway obstruction
- Rhinorrhea/Nasal discharge
- Persistent cough (daytime)
- Postnasal drip
- Headache
- Facial pain
- Foul breath
- Intermittent fever
- Caregiver (proxy responsible) able to read and understand English
- Has had at least 3 courses or a total of 21 days of oral antibiotic therapy for above symptoms in the previous 3 months
- Child has a CT scan of the coronal sinus without contrast within two months prior to visit date, which demonstrates and opacification of a single or multiple, ipsilateral or bilateral sinuses.
Exclusion Criteria:
- Inability of caregiver to read and understand English
- Mental retardation, cognitive impairment, or developmental delay
- History of cystic fibrosis
- History of immotile cilia syndrome
- History of immune suppression/immune compromise
- CT scan within past 4 weeks available for review at time of clinic visit which is entirely negative for evidence of sinus disease plus complete absence of any of the above symptoms
- History of endoscopic sinus surgery
- History of patient's inability to tolerate attempted nasal irrigation in the past 6 months
- History of recent use of gentamycin intranasal irrigation or saline irrigation within the past 3 months
- History of presence of nasal polyposis
- History of allergic reaction of any kind to intravenous gentamycin or aminoglycosides in past medical history (for treatment of any infections)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター:1
生理食塩水
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Intranasal Saline
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実験的:2
Saline plus Gentamycin
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Intranasal Saline
Intranasal irrigation
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Computed Tomography (CT) Score After Treatment
時間枠:Change from Baseline to 6 Weeks
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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.
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Change from Baseline to 6 Weeks
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Change in Overall Quality of Life
時間枠:3 Weeks to Follow-Up (7 Weeks)
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Measured by Quality of Life Survey (SN-5).
Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
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3 Weeks to Follow-Up (7 Weeks)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Overall Quality of Life
時間枠:Baseline to 3 Weeks
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Measured by Quality of Life Survey (SN-5).
Scores ranged from 0 - 7. The higher the numerical score, the worse the problem.
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Baseline to 3 Weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Julie L Wei, M.D.、University of Kansas Medical Center
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Salineの臨床試験
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Vinmec Healthcare System完了