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| ID | Type | Description | Link |
|---|---|---|---|
| No funding | Other Identifier | No issuing organization |
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This clinical study tested and compared two ways (cold-base technique or "cryoanesthesia" and conventional benzocaine gel) to reduce pain from dental injections in children.
Researchers worked with 28 children between 6 and 12 years old who needed injections on both sides of the lower jaw for dental treatment. Each child received cryoanesthesia on one side and 20% benzocaine gel on the other side, in different appointments, and the team measured pain, behavior, heart rate, and blood oxygen levels.
Objective: To evaluate and compare pain perception during inferior alveolar nerve block puncture in pediatric patients using cryoanesthesia versus conventional topical benzocaine anesthesia.
Methods: A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryanesthesia. Topical anesthesia using application of ice cones, before anesthesic punction. | Experimental | Ice cones were prepared using sterile, individual-sized latex gloves filled with purified, sterile water. The open end of each glove was sealed and the glove was placed in a freezer (temperature: -18°C to -20°C) for minimum 24 hours prior to use. This produced a textured ice cone of approximately 5 cm × 3 cm suitable for direct application to the infiltration site.
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| Benzocaine group: Topical anesthesia using 20% benzocaine, before anesthetic punction. | Active Comparator | Benzocaine 20% Topical Anesthesia Technique:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Anesthesia (lidocaine hydrochloride) | Procedure | After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique:
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| Measure | Description | Time Frame |
|---|---|---|
| Pain perception | Pain intensity was assessed using a validated instrument: Wong-Baker FACES® Pain Rating Scale (Visual Analog Scale): Immediately following completion of infiltration anesthesia injection, the participant was asked to indicate the level of pain experienced using the face scale (0 = no hurt to 10 = hurts worst). | Baseline: At the time of the anesthetic injection (or needle puncture) at the oral mucosa. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Continuous pulse oximetry monitoring was conducted using a calibrated pulse oximeter (typical brands: Nellcor or equivalent) with appropriate pediatric finger probe or reusable sensor. Measurement unit: Pulses per minute (ppm) for heart rate (HR), which were recorded at two time points:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amaury Pozos Guillén, Ph.D. | Universidad Autónoma de San Luis Potosi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Dentistry Postgraduate Program, Faculty of Denttistry | San Luis Potosà City | S.l.p. | 78990 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40110448 | Background | Ninawe N, Anija CK. Comparative Evaluation of Effectiveness of Benzocaine Gel and Ice for Pain Management in Children during Local Anesthetic Administration by CCLAD: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2025 Jan;18(1):19-23. doi: 10.5005/jp-journals-10005-3045. Epub 2025 Feb 14. | |
| 32617406 | Background |
| Label | URL |
|---|---|
| Step-by-step instructions for performing oral cryotherapy | View source |
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| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
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A split-mouth randomized controlled clinical trial was conducted with 28 patients aged 6 to 12 years requiring bilateral inferior alveolar nerve blocks for bilateral lower arch dental treatment. Each participant received both anesthetic techniques in a randomized order on separate appointments, with treatment allocated to contralateral mandibular hemiarches. Primary and secondary outcome measures included pain intensity (Visual Analog Scale), heart rate, oxygen saturation, and behavioral response (FLACC scale).
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| Local Anesthesia (lidocaine hydrochloride) | Procedure | After topical anesthesia (either technique), the clinician proceeded with conventional inferior alveolar nerve block using standardized technique:
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| Periprocedural: During the injection anesthetic procedure, from the anesthetic solution injection to the removal of the needle (approximately 45 seconds) |
| Oxygen saturation | Percentage of blood's hemoglobin carrying oxygen (normally 95-100%). Continuous pulse oximetry monitoring was conducted using a calibrated pulse oximeter (typical brands: Nellcor or equivalent) with appropriate pediatric finger probe or reusable sensor. Measurement units: SpO2 percentage (%), which was recorded at two time points: 1. Baseline measurement: Immediately before topical anesthetic application, with the participant in a calm resting state. And 2. During infiltration measurement: During active injection of local anesthetic solution into the infiltration site. | Periprocedural: During the injection anesthetic procedure, from the needle puncture to the removal of the needle (approximately 45 seconds). |
| Patient's behavioral response | Observable emotional and physiological reactions to the anesthetic injection through the FLACC (Facial expression, Legs, Activity, Cry, and Consolability) scale. Values: 0-10 (0 = relaxed, calm; 10 = severe distress). | Periprocedural: 45 seconds, from the anesthetic injection to the removal of the needle. |
| Tirupathi SP, Rajasekhar S. Effect of precooling on pain during local anesthesia administration in children: a systematic review. J Dent Anesth Pain Med. 2020 Jun;20(3):119-127. doi: 10.17245/jdapm.2020.20.3.119. Epub 2020 Jun 24. |
| 26379379 | Background | Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11. |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |