Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (RCT)
Effectiveness of Computerized Local Anesthesia in Reducing Local Anesthesia in Reducing Child Pain During Injection (Randomized Clinical Trial)
調査の概要
状態
詳細な説明
: the aim of this study is to evaluate star pen computerized Local Anaesthesia in reducing child pain during injection, and its impact on child behavior during extraction of primary molars.
Materials and Methods: The research will be conducted in the form of a double-blind randomized controlled clinical trial with a parallel design. A total of 40 healthy children aged 4-6 years will be selected from the Pediatric Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria, Egypt. Cooperative Children with Frankl behavioral rating scale scores of 3 or 4 will be selected. Each child chosen will have at least one maxillary or mandibular primary molar that requires extraction. The guardian's written informed consent will be obtained. Participants will be assigned into two groups of 20 children each based on the dental arch where the extraction will be performed: Group I (mandibular group); and Group II (maxillary group). Each group will be further subdivided into two subgroups: test group using the star pen computerized local anesthesia, and control group using the conventional method; IANB in the mandible, and infiltration local anesthesia in the maxilla according to the method of delivery of local anaesthesia. In the present study, pain during injection will be assessed by three methods: physiologically using the heart rate, objectively using Sound, Eye, Motor (SEM) scale, and subjectively using a modified face scale from the Maunuksela scale. In each child extraction of one primary molar will be performed according to the AAPD and child behavior will be assessed using Frankl Rating Scale.
Results: To obtain the study's results and conclusions, data will be collected, tabulated, and statistically analysed using SPSS version 26.0, with a significance level set at p < 0.05.
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
-
-
-
Alexandria、エジプト
- Pharos University in Alexandria
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Completion of the written informed consent form by parents/guardian.
- Children aged between 4 and 6 years.
- Medically fit patients classified as (ASA I).
- Cooperative children with a Frankl Behaviour Rating Scale of 3 or 4.
- Patients whom their primary molars are indicated for extraction, according to criteria of extraction of (AAPD).
Exclusion Criteria:
- Children with a history of allergy to local anaesthetic agents.
- Children who receive any analgesic drugs at least 24 h before treatment.
- Any inflammation or lesion in the injection site.
- Patients who have previous bad experience of dentistry to eliminate the possible impact of the child's previous painful or stressful experiences.
- Child coming for emergency treatment of pain.
- Teeth with ankylosed roots.
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Mandibular (IANB)
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CCLADS
infiltration or inferior alveolar local anesthesia
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実験的：Maxillary Infiltration
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CCLADS
infiltration or inferior alveolar local anesthesia
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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 |
|---|---|---|
|
heart rate
時間枠：The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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measuring heart rate by pulse oximeter
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The pulse oximeter will be placed on the patient's index finger to measure the the baseline heart rate (before giving the local anesthesia by 2 minutes), another measurement will be recorded during local anesthesia administration, and during extraction.
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Sound, Eye, Motor (SEM) Scale
時間枠：will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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objective method for pain assessment during LA administration scores from 1-->4 score 1=comfort(low score) score 4=severe discomfort (high score)
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will used as an objective method for pain assessment during anesthesia at end of injections immediately, after extraction immediately.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 460 - 6/01/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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