Pain perception of children during local anesthesia administration using BUZZY SYSTEM and CRYOANESTHESIA - A Randomized Clinical Trial

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2023/09/057831
• Lead Sponsor: Dr Muhammed Anushelque N

Brief Summary

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|Pain according to World Health Organization’s definition is “an unpleasant sensory or emotional experience associated with actual or potential tissue damageâ€.  Pain is an unavoidable part of dental procedures, and it is one of the leading causes of dental phobia in youngsters. Fear and anxiety-related behaviour, particularly during dental treatments, can be a substantial hindrance to dental care and can have a negative influence on a child’s overall oral health and well-being. The foundation of a good behaviour management programme is effective pain control in a pediatric patient during dental treatment, which is primarily accomplished with local anesthetic medications. In pediatric dental care, pain management is a significant part of anxiety, which is often related to the induction of pain and exacerbates pain perception. As a result, these individuals experience higher pain, which lasts longer and is associated with exaggerated pain memory. (1) According to Bienvenu and Eaton, children with needle phobia experienced unpleasant needle insertion in the past. (2) As a result, children may sense varying levels of pain from the same stimuli (e.g., dental injection). Okawa et al. suggested that children reported elevated dental pain when they were highly anxious. (3) Hmud and Walsh (2009) identified the "4S factors" for children’s dental anxiety; these include sights (e.g., feeling of uneasiness and worry), sounds (eg., of drilling), sensations (high-frequency vibrations), and smells (odors of eugenol and bonding agents). (4) According to Rachman, conditioning (direct response), modeling, and information (indirect responses) are three factors promoting dental anxiety in children. (5) Extreme pain can cause short-term or long-term physiological, psychological, and emotional consequences.  Administration of Local anesthesia (LA) is a common method for relieving dental discomfort associated with invasive treatments, such as tooth extractions and surgeries, although it can also be associated with non-invasive procedures, they are the safest and most effective drugs for pain prevention and management among all medicines nevertheless, needle-related procedures are common sources of fear and anxiety in youngsters, who have a natural aversion to sharp and pointed objects. (6) Prevention of pain can promote a positive relationship between the dentist and child, build trust, allay fear and anxiety, and inculcate positive dental attitudes for future treatment. (7) Even in children too young to speak, fear of pain is not frivolous: the consequences of untreated pain have an impact on medical outcomes and are recalled by preverbal children. (8) Inadequate pain management encourages negative responses and fear in children, making it difficult for dentists to instils a positive attitude in pediatric patients. As a result, every pediatric dentist’s main goal has become to treat children with the least amount of distress and pain possible. Hence developing strategies to reduce pain during injections is critical in preventing patients from postponing dental care. (9) To achieve a healthy child-dentist relationship, alleviate fear and anxiety, create trust and rapport, and instils a positive dental attitude for future consultations, it is critical to focus the child’s attention on the treatment and target their cognitive abilities. Basis of successful behaviour guidance is the effective management of pain in children during dental appointments. (10) Gold standard interventions for managing children experiencing needle-related pain is the Non-pharmacological behaviour guidance techniques.

Following are the Different non-pharmacological behaviour guidance techniques reported in the different literature including the: Tell-Show-Do (TSD), voice control, modeling, acupuncture, biofeedback, hypnosis, guided imagery, and distraction using storytelling, audio, or audio-visual aids, which target the psychological facet of the child; these are highly acceptable, as they do not result in repercussions. (11,12) Distraction is the process of diverting a child’s attention away from an unpleasant stimulus during dental operations. Distraction is a simple and inexpensive technique that cuts down on the amount of time and staff needed to complete the treatment.

Pre-cooling the injection site is one such option for reducing injection pain. Cold stimulation of the injection site prior to LA administration is a simple and physiologically successful treatment with no additional expenditures. (13) The use of gels in cold temperatures as a supplement to a vibrating device has recently shown promise. These vibrating devices are expected to create a distracting environment that will stimulate brain cells to transmit the vibrations, allowing the anesthetic to be given. The justification for employing both cold (temperature) and vibration (stimulation) is based on the idea that pain is a psychological component that requires the patient’s attention and observation. (14) Despite advancements in pediatric dentistry, injections continue to be a cause of discomfort and anxiety; unfortunately, no standard injection technique has so far been created.

The Buzzy system is a bee-shaped device with two parts: a bee’s body vibration and removable ice wings. Melzack and Wall’s (1965) gate control theory of pain and the descending inhibitory mechanism are the foundations of the Buzzy system. More specifically, the buzzy body’s vibration will block the afferent pain-receptive fibres (A-delta and C fibres), resulting in pain reduction. (15) Furthermore, when a prolonged cold treatment (30-60 seconds) is applied closer to the nociception site, the c-nociceptive fibres are activated, and the A-delta pain transmission signal is further blocked. (16)

Cryoanesthesia is the application of cold to a confined body part using refrigerant sprays or ice to prevent pain impulses from being transmitted by nerves. (17) Cold applied topically thereby excites myelinated A-fibers and stimulates inhibitory pain pathways. (17)  Cooling causes neuropraxia by reducing the tissue nociceptors threshold as well as the pain-carrying conduction nerve signals. (18) Precooling the soft tissue area reduces pain perception for infiltrations and block anesthesia in children during routine dental operations, according to Bose et al. (19) In a systematic review, Tirupathi and Rajasekhar found that precooling with ice lowers pain more than refrigerant spray before local anesthetic application. (20) Very few studies have been undertaken to evaluate the Buzzy® device’s efficacy in administering local anesthetic (LA) for dental procedures in pediatric patients since its invention. And there are hardly any studies been conducted to compare the efficacy of Buzzy® device with cryoanesthesia.

Thus, the purpose of this study is to determine the efficacy of a local anesthetic procedure using the Buzzy system versus cryoanesthesia for pain relief in children receiving local anesthesia injections, as well as to compare pain perception and patient comfort between the Buzzy system and Cryoanesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-04-09
• Study Start: 2023-10-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 1.Children requiring bilateral inferior alveolar nerve block administration.
• 2.Children classified as OUTWARDLY APPREHENSIVE and FEARFULL according to Lampshire’s classification of child’s behavior.
• 3.Children with parental consent.

Exclusion Criteria

• 1.Children with previous experience of LA administration.
• 2.Children with systemic illness.
• 3.Children with special health care needs / differently abled.
• 4.Children who are medically compromised.
• 5.Children who are allergic to local anesthetic agents.
• 6.Signs of inflammation or infection at the injection site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
For Outcome, we are considering null hypothesis as true. That is, there is no difference in the perception of pain either using buzzy system or cryoanesthesia during the administration of local anesthesia. Which will be assessed using Sound eye motor scale and acceptance using Wong- Baker faces pain rating scale.	1. Just before Procedure | 2. During Procedure | 3. Immediately after procedure

Trial Locations

Locations (1)

KVG Dental College And Hospital, Sullia; 🇮🇳 Kannada, KARNATAKA, India

KVG Dental College And Hospital, Sullia

🇮🇳Kannada, KARNATAKA, India

Dr Muhammed Anushelque N

Principal investigator

9656028343

anushelque@gmail.com