Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-11
SponsorBritish University In Egypt
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age group 7-11 years
Patients requiring infiltration anesthesia to fulfill dental therapeutic needs
Frankl behavior scale 3 and 4
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Dental anesthesia
BehavioralThe 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.
Treatment groups
224 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Precooling groupExperimental treatment 1 intervention
Group B: Precooling + topical anaesthesia groupExperimental treatment 1 intervention
Group C: Precooling + sweet tasting solution groupExperimental treatment 1 intervention
Group D: Precooling + sweet tasting solution + topical anaesthesiaExperimental treatment 1 intervention
Group E: Sweet tasting solution groupExperimental treatment 1 intervention
Group F: Sweet tasting solution + topical anaesthesia groupExperimental treatment 1 intervention
Group G: Topical anaesthesia groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Visual Analog Scale (VAS)
Pain Intensity assessed by visual analogue scale
Time frame
Immediately after interventionSecondary outcomes
1
Phase 1 outcome
The preferred sweet tasting solution based on number of patients
Time frame
After intervention2
Heart Rate
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and the maximum heart rate recorded during needle injection and after needle injection
Time frame
Heart rate (beats per minute) measured immediately before needle insertion (baseline) and during needle injection and after needle injection3
Sound, eye and motor scale (SEM) scale
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.
Time frame
During needle injection4
Oxygen saturation
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.
Time frame
Immediately before needle injection (baseline), during needle injection, and immediately after completion of injection. Recorded as percentageSponsors and contacts
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Source ClinicalTrials.gov