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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
El Sherouk
-
Cairo, El Sherouk, Egypte
- Recrutement
- Faculty of Dentistry, British University in Egypt
-
Contact:
- Nada M Farouk, post graduate student
- Numéro de téléphone: +21020668262
- E-mail: pg.nada92243007@bue.edu.eg
-
Contact:
- Ola A Abd El-geleel, Associate Professor
- Numéro de téléphone: +21006086830
- E-mail: ola@dent.asu.edu.eg
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Sous-enquêteur:
- Noha S Kabil, professor
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Chercheur principal:
- Nada M Farouk, bachelors degree
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Sous-enquêteur:
- Ola A Abd El-Geleel, associate professor
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Visual Analog Scale (VAS)
Délai: Immediately after intervention
|
Pain Intensity assessed by visual analogue scale |
Immediately after intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Phase 1 outcome
Délai: After intervention
|
The preferred sweet tasting solution based on number of patients |
After intervention
|
|
Heart Rate
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24-028
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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