To Evaluate the Paediatric Analgesia Slide
To Evaluate the Paediatric Analgesia Slide, a New Device Developed to Assist Parents in Administering Paracetamol to Children at Home
The Paediatric Analgesia Slide is a device developed for parents. Its development follows research into the Paediatric Analgesia Wheel, a device intended for use by hospital doctors. Previous research has shown the benefit of using aids such as the Paediatric Analgesia Wheel when simulating prescribing to children in hospital.
At present, it is unknown whether this concept can be extended to use by parents when administering paracetamol to their children at home.
調査の概要
状態
条件
詳細な説明
Prescribing and administering drugs to children is difficult for both healthcare professionals and parents. The process is often performed poorly with under-dosing and over-dosing a major problem with sometimes fatal consequences.
The British National Formulary for Children (BNFC), introduced in 2005, has given hospital and community prescribers with a valuable reference text.
However, the comprehensive prescribing information presented in the BNFC and in the drug Summary of Product Characteristics is simplified in the Patient Information Leaflet (PIL) for interpretation by parents. When the PIL is analysed, it becomes apparent that the age-range regimens presented may result in under and over-dosing with large differences in the daily dose received by children depending on their age and weight.
The Paediatric Analgesia Slide is a simple device presenting pre-calculated volume (and therefore dose) information for parents. It allows for age/weight specific doses to be given thus minimising the risk of under and over-dosing. It also addresses the deficiency of the prescribing information in the PIL related to over and under-weight children.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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England
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Darlington、England、イギリス、DL3 6HX
- County Durham and Darlington Acute Hospitals NHS Trust
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Any parent accompanying their child who is aged between 1 and 13 years old who is attending a hospital in County Durham and Darlington Acute Hospitals NHS Trust
Exclusion Criteria:
- Those who have professional knowledge of prescribing or dispensing medicine (e.g. as a doctor, nurse or pharmacist);
- Those who already have been given advice on the correct dose of paracetamol for their child as part of the current hospital episode;
- Those who's child is under 1 year or over 13 years old and;
- Those who have participated in this research before.
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
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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1
Using the information distributed with over-the-counter medication (The Patient Information Leaflet or PIL)
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2
Paediatric Analgesia Slide (the new device)
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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 |
時間枠 |
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Comparison of prescription accuracy using the information distributed with over-the-counter medication with the new device
時間枠：at data analysis
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at data analysis
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二次結果の測定
結果測定 |
時間枠 |
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Ability of parents to interpret the prescribing information related to minimum dosage interval and maximum dosage frequency
時間枠：at data analysis
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at data analysis
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To assess whether parents can accurately draw up the volume that they have stated in the primary objective
時間枠：at data analysis
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at data analysis
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協力者と研究者
捜査官
- 主任研究者：Richard C Hixson, BM BS, FRCA、County Durham and Darlington Acute Hospitals NHS Trust
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
痛みの臨床試験
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Dexa Medica Group完了