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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Première phase 1
Contacts et emplacements
Lieux d'étude
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Sindh
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Karachi, Sindh, Pakistan, 74200
- Abbasi Shaheed Hospital and Karachi Medical and Dental College
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain Intensity During Infiltration Injection Assessed by Visual Analogue Scale
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: FARWA MUHAMMAD, BACHELOR OF DENTAL SURGERY, Abbasi Shaheed Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- IRB/KMDC/KMU/26/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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