Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain in Children: A Randomized Controlled Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Patient reported pain during needle injection
Study Overview
Brief Summary
Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.
The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.
Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.
Detailed Description
The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
The statistician was only blinded for data analysis. But it was not feasible to blind the participant, investigator or the outcome assessor due to the nature of the study.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children in the mixed dentition stage,
- •Age range 6-12 years old,
- •Need extraction to a maxillary molar,
- •Cooperative and medically free.
Exclusion Criteria
- •Exclusion will be performed if the parent refused the participation of their children in the research.
Arms & Interventions
Buzzy device (cold and vibration)
Intervention: Buzzy device (cold and vibration) (Device)
Buzzy device (vibration only)
Intervention: Buzzy device (vibration only) (Device)
Precooling
Intervention: precooling (Other)
Flavored Benzocaine topical anesthetic gel 20%
Intervention: Flavored Benzocaine topical anesthetic gel 20% (Other)
Outcomes
Primary Outcomes
Patient reported pain during needle injection
Time Frame: Immediately post injection
Patient was asked to choose from the faces on the Wong Baker faces pain rating scale (0-10) with 10 is the worst score
Secondary Outcomes
- Child behaviour during needle injection(Immediately during injection)
- Heart rate(Immediately post injection)
- Oxygen saturation(Immediately post injection)
- Child and parent satisfaction(Immediately post injection)
Investigators
Fatma Abdelgawad
Associate Professor
Cairo University