NCT Number: NCT07835191
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.
Interested in participating?
Request Info7 year–11 year
All sexes
Interventional
Not applicable
Cairo, El Sherouk, Egypt
Location status: Recruiting
Nada M Farouk, bachelors degree
PRINCIPAL_INVESTIGATOR
Nada M Farouk, post graduate student
CONTACT
Noha S Kabil, professor
SUB_INVESTIGATOR
Ola A Abd El-Geleel, associate professor
SUB_INVESTIGATOR
Ola A Abd El-geleel, Associate Professor
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Immediately after intervention
Pain Intensity assessed by visual analogue scale
Time frame: After intervention
The preferred sweet tasting solution based on number of patients
Time frame: 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
Time frame: 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.
Time frame: 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.
British University In Egypt
Other
Efficacy of Pre-cooling and Sweet-tasting Solution on Pain Related to Local Anesthesia Injection in Children: A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07602686
Dental Anesthesia
Minneapolis, Minnesota, United States
View Trial DetailsNCT07622719
Behavior, Dental Anesthesia
Xi’an, Shanxi, China
View Trial DetailsNCT07592130
Dental Anesthesia, Emotional Anxiety and Stress During Pediatric Dental Treatment
View Trial DetailsNCT07288125
Cold Atmospheric Plasma, Dental Anesthesia
Kahramanmaraş, Turkey (Türkiye)
View Trial Details