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Topical Anesthetic Before Primary Molar Buccal Anesthesia is not Better than Placebo in Reducing Child’s Pain Perception
THERAPY
ARTICLE ANALYSIS
AND
EVALUATION
Topical Anesthetic Before Primary Molar Buccal Anesthesia is not Better than Placebo in Reducing Child’s Pain Perception ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION Efficacy of Intraoral Topical Anesthetics in Children Paschos E, Huth KC, Benz C, ReekaBardschmidt A, Hickel R. J Dent 2006;34(6):398-404.
LEVEL OF EVIDENCE 1b
PURPOSE/QUESTION To evaluate the efficacy of 4 different commercially available topical anesthetic materials in reducing pain during intraoral injections in children compared with a placebo.
SOURCE OF FUNDING Academic departmental sources
TYPE OF STUDY/DESIGN Randomized controlled trial (split mouth modification)
SUMMARY Subjects One hundred and four cooperative and “treatment experienced” children were enrolled, with 46 males and 58 females. Each required restorative treatment in both maxillary quadrants in primary molars, and were between 5 and 12 years old.
Therapy Before performing restorative dentistry in each of the 2 maxillary quadrants in the children at the same dental visit, either a topical anesthetic of 4 varieties or a placebo was selected, in advance of Ultracaine (articane) local anesthetic administration by injection for dental anesthesia purposes. The injection technique was typical and used a 30-gauge needle. It was during this injection procedure that “pain” was measured by 4 different established methods to compare the effect of each relative to a placebo in diminishing pain perception during the subsequent injection.
Main Outcome Measure The primary outcome variables were the Facial Pain Scale (FPS; 1 to 5 range) and the Heart Rate Change (using pulse oximeter as a measurement mechanism).
Main Results No statistically significant difference between the 4 anesthetics used and their placebo counterparts in attenuating the pain responses during injection as measured by the 2 primary variables. There were some reported differences for a couple of the anesthetics as they related to secondary variable outcomes, but the clinical significance was not deemed high. For Gingicain spray, one of the products used, there was order effect, in that when the topical anesthetic was used before the first injection, it outperformed its placebo counterpart in attenuating pain perception during subsequent injection. For one of the products, the Legecain-Solution, preschool-aged children responded more favorably when the secondary variable VAS (Visual Analog Scale) was analyzed compared with their placebo counterparts, relative to school-age children.
Conclusions The null hypothesis was not rejected; as the study showed no difference between 4 different topical anesthetic agents in children compared with placebo counterparts, in reducing pain perception during subsequent anesthetic injection. J Evid Base Dent Pract 2007;7:116-117
COMMENTARY AND ANALYSIS
1532-3382/$35.00 © 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2007.05.011
This study had some good design characteristics, but the power calculations did not address the issue of order effects. The authors did alternate
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
the placebo and topical anesthetic in each instance, but the order effect may not have been detectable because of the relatively small sample size and split mouth design. Additionally, the children were made aware (assumed from informed consent statement) in advance of both procedures and that 2 separate injection procedures would be performed at the same visit. This may well have raised their overall anxiety and pain perception, not allowing an otherwise differentiated response to be elucidated. There were many factors that could have affected the outcome in this study. Four different topical anesthetics plus placebos, at least 4 different pain perception measurement mechanisms, and 2 different operators (although they were calibrated) were used. The study was effective in raising many of the issues that occur during the use of topical anesthetic before administration of local anesthetic by injection in children; operator affect, physical distraction with the lip and via voice command, or verbal communication were not addressed. These fac-
Volume 7, Number 3
tors may be as or more significant than the topical anesthetic. Although these factors were not intended to be addressed in the present study, they may create sufficient noise as to render it difficult to detect the effect of the topical anesthetic. This well-done study provides some important questions to consider in designing future studies. Subsequent work should combine the affective domain of behavior management with the potential pharmaceutical benefit of topical anesthetic use in children.
REVIEWER Joel Berg, DDS, MS Professor and Chair Department of Pediatric Dentistry Box 357136 University of Washington Seattle, WA 98195 [email protected]
117
ARTICLE ANALYSIS
AND
EVALUATION
Topical Anesthetic Before Primary Molar Buccal Anesthesia is not Better than Placebo in Reducing Child’s Pain Perception ARTICLE TITLE AND BIBLIOGRAPHIC INFORMATION Efficacy of Intraoral Topical Anesthetics in Children Paschos E, Huth KC, Benz C, ReekaBardschmidt A, Hickel R. J Dent 2006;34(6):398-404.
LEVEL OF EVIDENCE 1b
PURPOSE/QUESTION To evaluate the efficacy of 4 different commercially available topical anesthetic materials in reducing pain during intraoral injections in children compared with a placebo.
SOURCE OF FUNDING Academic departmental sources
TYPE OF STUDY/DESIGN Randomized controlled trial (split mouth modification)
SUMMARY Subjects One hundred and four cooperative and “treatment experienced” children were enrolled, with 46 males and 58 females. Each required restorative treatment in both maxillary quadrants in primary molars, and were between 5 and 12 years old.
Therapy Before performing restorative dentistry in each of the 2 maxillary quadrants in the children at the same dental visit, either a topical anesthetic of 4 varieties or a placebo was selected, in advance of Ultracaine (articane) local anesthetic administration by injection for dental anesthesia purposes. The injection technique was typical and used a 30-gauge needle. It was during this injection procedure that “pain” was measured by 4 different established methods to compare the effect of each relative to a placebo in diminishing pain perception during the subsequent injection.
Main Outcome Measure The primary outcome variables were the Facial Pain Scale (FPS; 1 to 5 range) and the Heart Rate Change (using pulse oximeter as a measurement mechanism).
Main Results No statistically significant difference between the 4 anesthetics used and their placebo counterparts in attenuating the pain responses during injection as measured by the 2 primary variables. There were some reported differences for a couple of the anesthetics as they related to secondary variable outcomes, but the clinical significance was not deemed high. For Gingicain spray, one of the products used, there was order effect, in that when the topical anesthetic was used before the first injection, it outperformed its placebo counterpart in attenuating pain perception during subsequent injection. For one of the products, the Legecain-Solution, preschool-aged children responded more favorably when the secondary variable VAS (Visual Analog Scale) was analyzed compared with their placebo counterparts, relative to school-age children.
Conclusions The null hypothesis was not rejected; as the study showed no difference between 4 different topical anesthetic agents in children compared with placebo counterparts, in reducing pain perception during subsequent anesthetic injection. J Evid Base Dent Pract 2007;7:116-117
COMMENTARY AND ANALYSIS
1532-3382/$35.00 © 2007 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2007.05.011
This study had some good design characteristics, but the power calculations did not address the issue of order effects. The authors did alternate
JOURNAL OF EVIDENCE-BASED DENTAL PRACTICE
the placebo and topical anesthetic in each instance, but the order effect may not have been detectable because of the relatively small sample size and split mouth design. Additionally, the children were made aware (assumed from informed consent statement) in advance of both procedures and that 2 separate injection procedures would be performed at the same visit. This may well have raised their overall anxiety and pain perception, not allowing an otherwise differentiated response to be elucidated. There were many factors that could have affected the outcome in this study. Four different topical anesthetics plus placebos, at least 4 different pain perception measurement mechanisms, and 2 different operators (although they were calibrated) were used. The study was effective in raising many of the issues that occur during the use of topical anesthetic before administration of local anesthetic by injection in children; operator affect, physical distraction with the lip and via voice command, or verbal communication were not addressed. These fac-
Volume 7, Number 3
tors may be as or more significant than the topical anesthetic. Although these factors were not intended to be addressed in the present study, they may create sufficient noise as to render it difficult to detect the effect of the topical anesthetic. This well-done study provides some important questions to consider in designing future studies. Subsequent work should combine the affective domain of behavior management with the potential pharmaceutical benefit of topical anesthetic use in children.
REVIEWER Joel Berg, DDS, MS Professor and Chair Department of Pediatric Dentistry Box 357136 University of Washington Seattle, WA 98195 [email protected]
117