Evaluation of Computer-controlled Local Anesthesia in Children - a Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
Brief Summary
The goal of this clinical trial is to learn if Computer Controlled Local Anesthetic Delivery (CCLAD) results in lower pain during local anesthesia administration for infiltration in the buccal region of the upper jaw in patients between 6 and 16 years old who will receive a dental treatment.
The main questions it aims to answer are:
- Does CCLAD result in lower self-reported pain (Visual Analogue Scale (VAS) and Face Pain Scale-Revised (FPS-R)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment?
- Does CCLADD result in lower observed pain (Sound Eye Motor Scale (SEM)) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment?
- Does CCLAD result in lower hearth rate (HR) and galvanic skin response (GSR) for patients between 6 and 16 years old who need local anesthesia in the upper jaw for a dental treatment? Researchers will compare CCLAD (Dentapen, Septodont, France) to conventional local anesthesia infiltration with a metallic syringe to see if the infiltration is less painful in patients between 6 and 16 years old who will receive a dental treatment.
Participants will receive local anesthesia either with the Dentapen or metallic syringe.
- GSR and heart rate are measured before anesthesia, during needle insertion, at 0.3 - 0.6 - 0.9ml, and after anesthesia.
- Post-injection, the child provides VAS scores (if 8 years or older) and FPS-R (all patients).
- A researcher not administering the injection determines the SEM score.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients between the ages of 6 and 16 years
- •Requiring a buccal injection with local anesthesia for dental treatment, bilaterally in the upper jaw
- •Treatments: restorative filing, pulpotomy, extraction or a steel crown placement
- •At least one week between both treatments
- •Complying with the criteria of ASA I (ASA classification of The American Society of Anaesthesiologists, 1963)
- •Fluent in Dutch
- •Children who had a score of 3 or higher on the Frankl scale
Exclusion Criteria
- •Contraindications to inject Local anesthesia (allergy to the liquid, ...)
- •Patients referred because of needle phobia or behavior management problems
- •Refusing to sign the informed consent
Arms & Interventions
CCLAD
The CCLAD device is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline). It is set to 60sec/ml in continuous mode. All participants receive this intervention on one randomly assigned side of the mouth.
Intervention: Computer Controlled Local Anesthetic Delivery (CCLAD) (Device)
Conventional syringe
A conventional metallic syringe is used to administers local anesthesia with 1.2ml Septanest normal (4% articaine, 1/200000 adrenaline). All participants receive this intervention on one randomly assigned side of the mouth.
Intervention: Conventional metallic syringe (Device)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: Immediately after intervention, the child provides VAS scores.
The Visual Analog Scale is a self-report pain assessment tool applicable from the age of eight. The scale is a 100mm line, where 'no pain' is on the left and 'severe pain' is on the right. Patients indicate the level of pain experienced during local anesthesia by marking this scale. The scale is generally interpretted as follows: 0-4 mm (0-0.4): No pain or mild pain; 5-44 mm (0.5-4.4): Mild pain; 45-74 mm (4.5-7.4): Moderate pain; 75-100 mm (7.5-10): Severe pain. A higher score thus means a worse outcome.
Face Pain Scale-Revised (FPS-R)
Time Frame: Immediately after intervention, the child provides FPS-R scores.
The Face Pain Scale-Revised (FPS-R) is a self-report pain measurement tool. The scale consists of six gender neutral faces devoid of smiles or tears. Each face corresponds to a score ranging from zero to ten, with only the even numbers used. It is important to employ appropriate language while utilizing the FPS-R. You can use short phrases like 'this face means no pain' or 'this face means very much pain', avoiding the terms 'happy' and 'sad'. In this study the Face Pain Scale-Revised will be used from the age of six. The specific scores for each face from left to right are: 0, 2, 4, 6, 8, 10. A higher score means a worse outcome.
Secondary Outcomes
- Galvanic Skin Response (GSR)(GSR is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.)
- Heart rate (HR)(Heart rate is measured pre-intervention; periprocedurally during needle insertion at 0.3 - 0.6 - 0.9ml, and immediately after intervention.)
- Sound Eye Motor Scale (SEM)(A researcher not administering the injection determines the SEM score periprocedurally, from the start of injection until 1,2 minutes later when the injection has been completed.)