Pre-emptive Local Anesthesia and Emergence Behavior After Pediatric Dental General Anesthesia (PEDLA-QOR)
Effects of Pre-emptive Local Anesthesia on Emergence Behavior and Early Recovery Quality After Ambulatory Pediatric Dental General Anesthesia: A Parallel-Group Randomized Controlled Trial
調査の概要
状態
詳細な説明
This is a prospective, single-center, assessor-blinded, parallel-group randomized controlled trial in children aged 7-12 years undergoing ambulatory dental treatment under general anesthesia.
Participants will be randomized in a 1:1 ratio to one of two groups: pre-emptive local anesthesia or no local anesthesia. In the pre-emptive local anesthesia group, local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area. In the no local anesthesia group, local anesthesia will not be routinely administered. If clinically required, rescue analgesia or additional local anesthesia may be administered at the discretion of the responsible clinician and will be recorded.
Preoperative anxiety will be assessed using the modified Yale Preoperative Anxiety Scale. In the post-anesthesia care unit, sedation and arousal will be assessed using the Richmond Agitation-Sedation Scale before each behavioral and pain assessment. Emergence behavior will be evaluated using a PAED-derived 3-item emergence behavior assessment at 0, 5, 10, 15, and 30 minutes after arrival in the post-anesthesia care unit, only when the child meets predefined arousal criteria. Pain will be assessed using the Faces Pain Scale-Revised at the same time points. Recovery quality before discharge will be assessed using the QoR-15 Pictorial form.
The study aims to determine whether reducing peri-emergence nociceptive input with pre-emptive local anesthesia improves early emergence behavior, postoperative pain, and recovery quality in children undergoing ambulatory dental general anesthesia.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Seher Orbay Yaşlı, Assistant Professor of Anesthe
- 電話番号：+905052401933
- メール：sehersin81@hotmail.com
研究場所
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Kayseri
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Kayseri、Kayseri、トルコ（Türkiye）、38039
- Erciyes University Faculty of Dentistry
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コンタクト：
- SEHER Orbay Yaşlı
- 電話番号：05052401933
- メール：sehersin81@hotmail.com
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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:
- Children aged 7 to 12 years
- ASA physical status I or II
- Scheduled for ambulatory dental treatment under general anesthesia
- Ability to understand and respond to age-appropriate pain and recovery assessment tools
- Written informed consent obtained from a parent or legal guardian
- Child assent obtained when appropriate
Exclusion Criteria:
- Known allergy or contraindication to local anesthetic agents
- Developmental delay or cognitive impairment preventing assessment
- Autism spectrum disorder or severe behavioral disorder
- Neurological disease affecting behavior or consciousness
- Chronic analgesic or sedative medication use
- Severe hepatic, renal, cardiac, or respiratory disease
- Emergency dental procedure
- Need for postoperative hospital admission
- Inability to complete postoperative assessment tools
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：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：Pre-emptive Local Anesthesia
Children randomized to this group will receive pre-emptive local anesthesia administered by the pediatric dentist before the dental procedure under general anesthesia.
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Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area.
The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
Pre-emptive local anesthesia will be administered by the pediatric dentist before the dental procedure according to the planned treatment area.
The local anesthetic agent, total volume, total dose, dose per kilogram, and injection sites will be recorded.
Articaine hydrochloride with epinephrine will be administered as local anesthesia by the pediatric dentist before the dental procedure in participants randomized to the pre-emptive local anesthesia group.
The total volume, total dose, dose per kilogram, and injection sites will be recorded.
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介入なし：No Local Anesthesia
Children randomized to this group will undergo dental treatment under general anesthesia without routine pre-emptive local anesthesia.
Rescue analgesia or additional local anesthesia may be administered if clinically required and will be recorded.
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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 |
|---|---|---|
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Emergence Behavior Score During the First 30 Minutes in the Post-Anesthesia Care Unit
時間枠：PACU minutes 0, 5, 10, 15, and 30
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Emergence behavior will be assessed using a PAED-derived 3-item emergence behavior assessment including eye contact, purposeful behavior, and awareness of surroundings.
Each item is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate greater emergence behavior disturbance.
Assessments will be performed only when the Richmond Agitation-Sedation Scale score is ≥ -1.
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PACU minutes 0, 5, 10, 15, and 30
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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 |
|---|---|---|
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Postoperative Pain Score
時間枠：PACU minutes 0, 5, 10, 15, and 30
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Pain will be assessed using the Faces Pain Scale-Revised.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
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PACU minutes 0, 5, 10, 15, and 30
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Recovery Quality Before Discharge
時間枠：Before discharge on day of surgery
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Recovery quality will be assessed using the QoR-15 Pictorial form before discharge.
The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery quality.
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Before discharge on day of surgery
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
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
- PEDGA-LA-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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創発せん妄の臨床試験
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Bozok University募集術後合併症 | 小児患者 | 術前不安（Ameliyat Öncesi Anksiyete） | Emergence Delirium (覚醒時せん妄)トルコ（Türkiye）