Comparing Pain Levels With or Without Topical Anesthesia During Infiltration Injection in Patients Undergoing Tooth Extraction.
Evaluating the Efficacy of Topical Anesthesia in Alleviating Pain During Infiltrate Injection in Abbasi Shaheed Hospital/KMDC
調査の概要
状態
条件
詳細な説明
This randomized clinical trial is designed to evaluate the effectiveness of 5% topical lidocaine in reducing pain associated with infiltration anesthesia in patients undergoing tooth extraction. Pain during local anesthetic administration remains a common cause of anxiety and fear among dental patients and may negatively affect treatment acceptance, patient cooperation, and overall clinical experience.
The study will be conducted at the Department of Oral and Maxillofacial Surgery, Abbasi Shaheed Hospital, and the Department of Oral Surgery, KMDC. A total of 120 eligible adult patients requiring tooth extraction will be recruited after obtaining informed consent. Participants will be randomly allocated into two groups using sealed opaque envelopes. Group A will receive conventional infiltration anesthesia with 2% lidocaine alone, while Group B will receive 5% topical lidocaine prior to administration of 2% lidocaine infiltration anesthesia.
The primary outcome measure will be pain intensity, assessed using the Visual Analogue Scale (VAS). Pain scores will be recorded at 5, 15, and 30 minutes following the procedure. Relevant demographic and clinical variables, including age, gender, smoking status, diabetes mellitus, and hypertension, will also be collected to evaluate potential confounding factors.
The intervention poses minimal risk to participants, as both topical and infiltrative lidocaine are routinely used and well-established agents in dental practice. Patients with known allergies to lidocaine, pregnant or lactating women, and individuals unwilling to participate will be excluded to ensure participant safety. All participants will receive the standard of care required for tooth extraction irrespective of study allocation.
The anticipated benefit of this study is the generation of evidence regarding the effectiveness of topical anesthesia as an adjunctive measure for reducing injection-related pain. The findings may contribute to improved patient comfort, reduced anxiety, enhanced treatment acceptance, and optimization of pain management protocols in routine dental practice.
研究の種類
入学 (推定)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
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Sindh
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Karachi、Sindh、パキスタン、74200
- Abbasi Shaheed Hospital and Karachi Medical and Dental College
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- patients aged 18-65 years of age who underwent extraction of tooth.
- no intolerance or allergies to lidocaine 2% infiltration and lidocaine 5% topical.
- Patients should not take sedative analgesics or anxiety medications in the 12 hour prior to extraction
Exclusion Criteria:
- Pregnant or lactating women.
- Patient not giving consent to undergo the procedure.
- Patient with occurrence of skin or mucosal allergy or abnormal reaction at the vascular access site.
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：なし（オープンラベル）
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：Arm Type 1: Placebo Comparator (2% lidocaine hydrochloride infiltration injection alone)
Arm 1: Control Group Title: 2% lidocaine hydrochloride injection Description: Participants receive conventional 2% lidocaine hydrochloride infiltration anesthesia without prior application of topical lidocaine. |
Participants assigned to Arm 1 will receive conventional local anesthesia using a 2% lidocaine hydrochloride infiltration injection before tooth extraction.
No topical anesthetic will be applied prior to the injection.
This arm serves as the control group and represents the standard practice against which the effect of pre-injection topical lidocaine anesthesia will be compared.
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実験的：A2: Experimental (5% topical lidocaine hydrochloride preparation+2% lidocaine hydrochloride injecti
Arm 2: Experimental Group Title: Topical 5% Lidocaine hydrochloride preparation Plus 2% lidocaine hydrochloride Infiltration injection Description: Participants receive 5% topical lidocaine hydrochloride preparation before administration of 2% lidocaine hydrochloride infiltration injection. |
Participants assigned to Arm 1 will receive conventional local anesthesia using a 2% lidocaine hydrochloride infiltration injection before tooth extraction.
No topical anesthetic will be applied prior to the injection.
This arm serves as the control group and represents the standard practice against which the effect of pre-injection topical lidocaine anesthesia will be compared.
Participants assigned to Arm 2 will receive 5% topical lidocaine applied to the mucosal injection site before administration of a 2% lidocaine hydrochloride infiltration injection for tooth extraction.
The topical anesthetic is administered as a pre-treatment to reduce pain and discomfort associated with needle insertion and anesthetic infiltration.
This arm represents the experimental intervention and will be compared with the control group receiving infiltration anesthesia alone.
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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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Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
時間枠：5 minutes, 15 minutes, and 30 minutes post-procedure
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Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure
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5 minutes, 15 minutes, and 30 minutes post-procedure
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Pain Score (Visual Analogue Scale)
時間枠：5 minutes, 15 minutes, and 30 minutes post-procedure
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Pain intensity following infiltration injection will be assessed using a 0-10 cm Visual Analogue Scale (VAS) at 5, 15, and 30 minutes after the procedure.
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5 minutes, 15 minutes, and 30 minutes post-procedure
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協力者と研究者
スポンサー
捜査官
- 主任研究者：FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY、Abbasi Shaheed Hospital
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 (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
その他の研究ID番号
- IRB/KMDC/KMU/26/2025
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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