Comparative Evaluation of Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) via Electronic Acupuncture Pen and Cryotherapy for Minimizing Pain Before Local Anesthesia Administration in 7-10-Year-Old Children: A Randomized Control Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- successfully administering painless local anesthesia in pediatric patients.
Study Overview
Brief Summary
The main concern of the pediatric dentist is to achieve the cooperation of the child in the dental clinic during various pediatric procedures. Administering anesthesia to pediatric patients proves to be the most challenging part of the process. The real fear of the child during a pediatric procedure is painful local anesthetic (LA) injections. Reducing the fear of pain during LA injections gains the confidence of the child toward the dentist, thus achieving the cooperation of the child during treatment [Patil et al., 2021]. Over the years, topical anesthetics have been used to prepare injection sites before needle penetration. Nakanishi et al. found that the site of injection plays an essential role in the efficacy of topical anesthetic agents as they produce surface anesthesia and have a limited capacity to penetrate deep into tissues. Although the discomfort due to surface penetration is reduced, they are ineffective at greater penetration depths which are required for regional block injections such as the IANB [Choudhari et al.,2017].
Pediatric dentists are persistently in search of techniques, which may present a more relaxing dental experience. Cryotherapy application is one of the endorsed strategies for reducing pain perception in patients that would be effective, efficient, and cost-effective. It is the application of ice or refrigerant spray on the anesthetic site to counter nerve conduction of pain from the site [Lakshmanan et al.,2021]. The use of acupuncture is a traditional Chinese medical technique for treating pain. There are various types of acupuncture techniques, out of which electro-acupuncture is one where electrical stimulation of a point with acupuncture needles is used. However, pain due to needle insertion persists. So, acupuncture needles are replaced by TENS therapy to stimulate superficial nerves for localized pain relief. With this technology, an electronic acupuncture pen has been devised, and is a non-invasive method for producing local analgesia [Deulkar et al.,2023]. Allgood defined TENS as direct stimulation of the nerves by electrical impulses of short duration and small amplitude. Shane and Kessler in 1967 first described its use in various fields related to medicines. TENS and cryotherapy work on the principle of gate control theory given by Melzack and Wall in 1965. The application of ice and TENS provides physiological as well as psychological benefits to the patients as it may distract them from focusing on their discomfort. Thus, this study was planned to evaluate the effectiveness of TENS via electronic acupuncture pen, cryotherapy, and 2% benzocaine gel to alleviate pain before LA administration in children aged 7-10 years.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 7.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy & cooperative children.
- •Children aged between 7 and 10 years.
- •Children with no prior experience of dental injection (LA).
- •Children requiring IANB for dental treatment.
- •Children with Frankl’s behaviour III & IV.
Exclusion Criteria
- •Children with systemic illness or medically compromised.
- •Children with special healthcare needs.
- •Children with history of dental injection.
- •Children allergic to LA agents.
- •Children with Frankl’s behaviour I & II.
Outcomes
Primary Outcomes
successfully administering painless local anesthesia in pediatric patients.
Time Frame: one and half year
Secondary Outcomes
- To compare all three groups i.e. TENS, Cryotherapy, Topical anesthetic gel, & to determine their effectiveness in minimizing pain during inferior alveolar nerve block in pediatric Patients.(one & half year)
Investigators
Dr Waseem Fatima
Army College of Dental Sciences
