Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children
Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
The study aims to determine whether pre-cooling and sweet-tasting solutions, alone or combined with topical anesthesia, provide better pain control during dental local anesthesia in children.
It has two phases:
Phase 1: Identify the children's preferred sweet-tasting solution among xylitol, monk fruit, erythritol, and honey.
Phase 2: A randomized controlled trial comparing 7 groups involving pre-cooling, sweet solution, topical anesthesia, and their combinations.
The primary outcome is pain measured by VAS, while secondary outcomes include SEM behavioral response, heart rate, and oxygen saturation. The planned sample is 220 children.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
El Sherouk
-
Cairo、El Sherouk、エジプト
- 募集
- Faculty of Dentistry, British University in Egypt
-
コンタクト：
- Nada M Farouk, post graduate student
- 電話番号：+21020668262
- メール：pg.nada92243007@bue.edu.eg
-
コンタクト：
- Ola A Abd El-geleel, Associate Professor
- 電話番号：+21006086830
- メール：ola@dent.asu.edu.eg
-
副調査官：
- Noha S Kabil, professor
-
主任研究者：
- Nada M Farouk, bachelors degree
-
副調査官：
- Ola A Abd El-Geleel, associate professor
-
-
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:
- Age group 7-11 years
- Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
- Frankl behavior scale 3 and 4
Exclusion Criteria:
- Failure to provide assent or consent
- Allergy from local anesthetic solution
- Systemic diseases such as diabetes that could affect pain perception
- History of abscess or fistula at site of injection
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：支持療法
- 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 |
|---|---|
|
実験的：Precooling group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
実験的：Precooling + topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
実験的：Precooling + sweet tasting solution group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
実験的：Precooling + sweet tasting solution + topical anaesthesia
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
実験的：Sweet tasting solution group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
実験的：Sweet tasting solution + topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
|
アクティブコンパレータ：Topical anaesthesia group
|
The intervention consists of pre-cooling and/or a sweet-tasting solution, used alone or in combination with topical local anesthesia, before administration of the dental local anesthetic injection. |
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 |
|---|---|---|
|
Visual Analog Scale (VAS)
時間枠：Immediately after intervention
|
Pain Intensity assessed by visual analogue scale |
Immediately after intervention
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Phase 1 outcome
時間枠：After intervention
|
The preferred sweet tasting solution based on number of patients |
After intervention
|
|
Heart Rate
時間枠：Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection
|
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection |
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection
|
|
Sound, eye and motor scale (SEM) scale
時間枠：During needle injection
|
Behavioral pain response during local anesthetic injection assessed using the Sound, Eye, and Motor (SEM) Scale. Sound, eye, and motor responses are each scored from 1 to 4, with 1 indicating comfort and 4 indicating a painful response. The three component scores are summed to obtain a total SEM score ranging from 3 to 12, with higher scores indicating greater behavioral response to pain. |
During needle injection
|
|
Oxygen saturation
時間枠：Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage at three time points: immediately before local anesthetic needle injection (baseline), during needle injection, and immediately after completion of the injection. |
Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentage
|
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 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- 24-028
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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