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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
El Sherouk
-
Cairo, El Sherouk, Egypten
- Rekrytering
- Faculty of Dentistry, British University in Egypt
-
Kontakt:
- Nada M Farouk, post graduate student
- Telefonnummer: +21020668262
- E-post: pg.nada92243007@bue.edu.eg
-
Kontakt:
- Ola A Abd El-geleel, Associate Professor
- Telefonnummer: +21006086830
- E-post: ola@dent.asu.edu.eg
-
Underutredare:
- Noha S Kabil, professor
-
Huvudutredare:
- Nada M Farouk, bachelors degree
-
Underutredare:
- Ola A Abd El-Geleel, associate professor
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Experimentell: 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. |
|
Aktiv komparator: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Visual Analog Scale (VAS)
Tidsram: Immediately after intervention
|
Pain Intensity assessed by visual analogue scale |
Immediately after intervention
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phase 1 outcome
Tidsram: After intervention
|
The preferred sweet tasting solution based on number of patients |
After intervention
|
|
Heart Rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 24-028
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