Last reviewed · How we verify
Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) Device in Reducing Pain Among Children 6-14 Years During Dental Treatments in a Randomized Cross-over Clinical Trial
Dental Fear and Anxiety (DFA) are at higher levels among children and often leads to avoidance of dental treatment. Negative experiences in the early years such as experience of pain during injections, fillings, or extractions may lead to difficulties in treatment and behavior management among children. During dental procedures such as restorations and extractions injectable anesthetics are required as they are used to anesthetize and numb the area around the tooth receiving treatment. Topical anesthetics are used prior to using injectable anesthetic to alleviate some pain and discomfort. Topical anesthetics should be used with caution as they consist of more concentrated doses of pharmaceutical elements used in injectable anesthetics. Such high concentrations can result in increased gag reflux, central nervous system depression and cardiovascular effects in rare cases. With many recent advances in dental treatment, there is also a need for new non-pharmaceutical strategies to alleviate pain and discomfort among children which in turn will motivate children and their parents to visit the dental clinic more frequently. Electronic anesthesia or Synapse Transcutaneous Electronic Nerve Stimulation (TENS), a non-invasive device that uses low energy electrical stimulation to reduce pain perception, has gained acceptance since the 1990s. Advantages of using the TENS device are that it is safe, easy to use, well-accepted among patients as evidenced in the few trials conducted so far, no adverse complications and has been successful in alleviating pain during dental procedures. This study aims to explore use of the TENS to alleviate pain and discomfort at the oral mucosal site where the patient will receive a local anesthetic injection. In this randomized case-crossover trial among children aged 6-14 years the effectiveness of Aleve TENS device in reducing pain and anxiety among children prior to receiving injectable local anesthetic agent during dental procedures is compared to those who receive the local anesthetic gel prior to receiving local anesthetic injection.
Details
| Lead sponsor | Boston University |
|---|---|
| Phase | NA |
| Status | WITHDRAWN |
| Start date | 2021-07 |
| Completion | 2023-02 |
Conditions
- Dental Fear
- Anesthesia, Local
- Pediatric Dentistry
Interventions
- Synapse TENS device
- Topical anesthetic gel
Primary outcomes
- Presence of Pain before treatment — before the start of each treatment procedure up to 6 months
The presence of pain will be a simple question in the case report form with two answer choices: yes or no. - Presence of Pain before local analgesic injection — after TENS or gel administration before local analgesic injection at about 1 minute
The presence of pain will be a simple question in the case report form with two answer choices: yes or no. - Presence of Pain after treatment — about 45 minutes at the end of the treatment visit
The presence of pain will be a simple question in the case report form with two answer choices: yes or no. - Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale — before the start of each treatment procedure up to 6 months
Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned. - Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale — after TENS or gel administration before local analgesic injection at about 1 minute
Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned. - Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale — about 45 minutes at the end of the treatment visit
Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.
Countries
United States