Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial.

OBJECTIVE: Pain due to administration of local anesthetics is the primary reason for patients' fear and anxiety, and various methods are used to minimize it. This study aimed to measure the degree of pain during administration of anesthesia and determine the latency time and duration of pulpal anesthesia using two anesthetic methods in the maxilla. MATERIALS AND METHODS: A randomized, single-blind, split-mouth clinical trial was conducted with 41 volunteers who required class I restorations in the maxillary first molars. Local anesthesia was administered with a needleless jet injection system (experimental group) or with a carpule syringe (control) using a 30-gauge short needle. The method of anesthesia and laterality of the maxilla were randomized. A pulp electric tester measured the latency time and duration of anesthesia in the second molar. Visual analogue scale (VAS) was used to measure the degree of pain during the anesthetic method. Data were tabulated and then analyzed by a statistician. The t-test was used to analyze the differences between the groups for basal electrical stimulation. Duration of anesthesia and degree of pain were compared using the Mann-Whitney test. A 5% significance level was considered. RESULTS: There was no statistical difference in the basal electrical stimulation threshold (mA) and degree of pain between the two methods of anesthesia (p>0.05). Latency time was 2 minutes for all subjects. The duration of pulpal anesthesia showed no statistical difference (minutes) between the two methods (p<0.001), with a longer duration for the traditional method of anesthesia (median of 40 minutes). CONCLUSIONS: The two anesthetics methods did not differ concerning the pain experienced during anesthesia. Latency lasted 2 minutes for all subjects; the traditional infiltration anesthesia resulted in a longer anesthetic duration compared with the needleless jet injection.

Assessment of anesthetic properties and pain during needleless jet injection anesthesia: a randomized clinical trial

Abstract Pain due to administration of local anesthetics is the primary reason for patients' fear and anxiety, and various methods are used to minimize it. This study aimed to measure the degree of pain during administration of anesthesia and determine the latency time and duration of pulpal anesthesia using two anesthetic methods in the maxilla. Materials and Methods: A randomized, single-blind, split-mouth clinical trial was conducted with 41 volunteers who required class I restorations in the maxillary first molars. Local anesthesia was administered with a needleless jet injection system (experimental group) or with a carpule syringe (control) using a 30-gauge short needle. The method of anesthesia and laterality of the maxilla were randomized. A pulp electric tester measured the latency time and duration of anesthesia in the second molar. Visual analogue scale (VAS) was used to measure the degree of pain during the anesthetic method. Data were tabulated and then analyzed by a statistician. The t-test was used to analyze the differences between the groups for basal electrical stimulation. Duration of anesthesia and degree of pain were compared using the Mann-Whitney test. A 5% significance level was considered. Results: There was no statistical difference in the basal electrical stimulation threshold (mA) and degree of pain between the two methods of anesthesia (p>0.05). Latency time was 2 minutes for all subjects. The duration of pulpal anesthesia showed no statistical difference (minutes) between the two methods (p<0.001), with a longer duration for the traditional method of anesthesia (median of 40 minutes). Conclusions: The two anesthetics methods did not differ concerning the pain experienced during anesthesia. Latency lasted 2 minutes for all subjects; the traditional infiltration anesthesia resulted in a longer anesthetic duration compared with the needleless jet injection.

Endoscopic gastric submucosal dissection: experimental comparative protocol between standard technique and Hybrid-Knife(r) / Dissecção endoscópica submucosa gástrica: protocolo experimental comparativo entre a técnica convencional e o Hybrid-Knife(r)

ABSTRACT Background Endoscopic treatment of superficial gastrointestinal tumors is routinely performed, however the advantages and shortcomings of submucosal pressure-jet dissection is still debated. Objective - Aiming to compare this technique with conventional submucosal dissection, a study was designed in pigs. Methods - Areas of the antral mucosa of the stomach with a diameter of 2 cm2 (6 per animal) were marked, and resected by means of the hybrid-knife (experimental technique), and Flush-knife or IT-knife (controls). An ERBE ICC 300 electrosurgical unit was adopted. End-points were procedural time, complications, and quality of the resected specimen. Results - A total of 27 interventions were conducted in five animals. Time spent with the two options was quite short, and similar: 9.5±3.1 vs 8.0±3.0 minutes (P=0.21). Complications didn't differ (three per group, not significant), and removed specimen looked adequate in both circumstances. Conclusion - The hybrid-knife technique is an acceptable alternative to submucosal dissection, showing no difference compared to the standard technique taking into consideration the procedure, the presence of complications and the quality of the resected specimen.

RESUMO Contexto O tratamento endoscópico de tumores gastrointestinais superficiais é realizado rotineiramente, no entanto as vantagens e deficiências da dissecção submucosa com jato de pressão ainda é debatido. Objetivo - Visando comparar esta técnica com dissecção submucosa convencional, um estudo foi realizado em suínos. Métodos - Áreas da mucosa antral do estômago com um diâmetro de 2 cm2 (um total de 6 por animal) foram marcadas, e a ressecção através do hybrid-knife (técnica experimental), e do Flush-knife ou IT-knife (controles). Uma unidade eletro cirúrgica ERBE ICC 300 foi adotada. Os desfechos foram: tempo do procedimento, complicações e qualidade da amostra ressecada. Resultados - Um total de 27 intervenções foram realizadas em cinco animais. O tempo gasto com as duas técnicas foi curto e semelhante: 9,5±3,1 vs 8,0±3,0 minutos (P=0,21). As complicações não diferiram (três por grupo, não significativas), e amostras retiradas foram adequadas em ambas as circunstâncias. Conclusão - A técnica de hybrid-knife é uma alternativa aceitável para dissecção submucosa, demonstrando não haver diferença em comparação à técnica convencional levando em consideração o tempo de procedimento, a presença de complicações e a qualidade da amostra ressecada.

ENDOSCOPIC GASTRIC SUBMUCOSAL DISSECTION: experimental comparative protocol between standard technique and Hybrid-Knife(r).

BACKGROUND: Endoscopic treatment of superficial gastrointestinal tumors is routinely performed, however the advantages and shortcomings of submucosal pressure-jet dissection is still debated. OBJECTIVE: - Aiming to compare this technique with conventional submucosal dissection, a study was designed in pigs. METHODS: - Areas of the antral mucosa of the stomach with a diameter of 2 cm2 (6 per animal) were marked, and resected by means of the hybrid-knife (experimental technique), and Flush-knife or IT-knife (controls). An ERBE ICC 300 electrosurgical unit was adopted. End-points were procedural time, complications, and quality of the resected specimen. RESULTS: - A total of 27 interventions were conducted in five animals. Time spent with the two options was quite short, and similar: 9.5±3.1 vs 8.0±3.0 minutes (P=0.21). Complications didn't differ (three per group, not significant), and removed specimen looked adequate in both circumstances. CONCLUSION: - The hybrid-knife technique is an acceptable alternative to submucosal dissection, showing no difference compared to the standard technique taking into consideration the procedure, the presence of complications and the quality of the resected specimen.

Needle-free jet injector intradermal delivery of fractional dose inactivated poliovirus vaccine: Association between injection quality and immunogenicity.

INTRODUCTION: The World Health Organization recommends that as part of the polio end-game strategy a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries currently using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5 of full dose) IPV (fIPV) by intradermal (ID) injection may reduce costs, but its conventional administration is with Bacillus Calmette-Guerin (BCG) needle and syringe (NS), which is time consuming and technically challenging. We compared injection quality achieved with BCG NS and three needle-free jet injectors and assessed ergonomic features of the injectors. METHODS: Children between 12 and 20 months of age who had previously received OPV were enrolled in the Camaguey, Cuba study. Subjects received a single fIPV dose administered intradermally with BCG NS or one of three needle-free injector devices: Bioject Biojector 2000® (B2000), Bioject ID Pen® (ID Pen), or PharmaJet Tropis® (Tropis). We measured bleb diameter and vaccine loss as indicators of ID injection quality, with desirable injection quality defined as bleb diameter ≥5mm and vaccine loss <10%. We surveyed vaccinators to evaluate ergonomic features of the injectors. We further assessed the injection quality indicators as predictors of immune response, measured by increase in poliovirus neutralizing antibodies in blood between day 0 (pre-IPV) and 21 (post-vaccination). RESULTS: Delivery by BCG NS and Tropis resulted in the highest proportion of subjects with desirable injection quality; health workers ranked Biojector2000 and Tropis highest for ergonomic features. We observed that vaccine loss and desirable injection quality were associated with an immune response for poliovirus type 2 (P=0.02, P=0.01, respectively). CONCLUSIONS: Our study demonstrated the feasibility of fIPV delivery using needle-free injector devices with high acceptability among health workers. We did not observe the indicators of injection quality to be uniformly associated with immune response.

Immune responses after fractional doses of inactivated poliovirus vaccine using newly developed intradermal jet injectors: a randomized controlled trial in Cuba.

INTRODUCTION: The World Health Organization recommends that, as part of the new polio endgame, a dose of inactivated poliovirus vaccine (IPV) be introduced by the end of 2015 in all countries using only oral poliovirus vaccine (OPV). Administration of fractional dose (1/5th of full dose) IPV (fIPV) intradermally may reduce costs, but its administration is cumbersome with BCG needle and syringe. We evaluated performance of two newly developed intradermal-only jet injectors and compared the immune response induced by fIPV with that induced by full-dose IPV. METHODS: Children between 12 and 20 months of age, who had previously received two doses of OPV, were enrolled in Camaguey, Cuba. Subjects received a single dose of IPV (either full-dose IPV intramuscularly with needle and syringe or fIPV intradermally administered with one of two new injectors or with BCG needle or a conventional needle-free injector). Serum was tested for presence of poliovirus neutralizing antibodies on day 0 (pre-IPV) and on days 3, 7 and 21 (post-vaccination). RESULTS: Complete data were available from 74.2% (728/981) subjects. Baseline median antibody titers were 713, 284, and 113 for poliovirus types 1, 2, and 3, respectively. Seroprevalence at study end were similar across the intervention groups (≥ 94.8%). The immune response induced with one new injector was similar to BCG needle and to the conventional injector; and superior to the other new injector. fIPV induced significantly lower boosting response compared to full-dose IPV. No safety concerns were identified. INTERPRETATION: One of the two new injectors demonstrated its ability to streamline intradermal fIPV administration, however, further investigations are needed to assess the potential contribution of fIPV in the polio endgame plan.

Incremental costs of introducing jet injection technology for delivery of routine childhood vaccinations: comparative analysis from Brazil, India, and South Africa.

BACKGROUND: Disposable-syringe jet injectors (DSJIs) have the potential to deliver vaccines safely and affordably to millions of children around the world. We estimated the incremental costs of transitioning from needles and syringes to delivering childhood vaccines with DSJIs in Brazil, India, and South Africa. METHODS: Two scenarios were assessed: (1) DSJI delivery of all vaccines at current dose and depth; (2) a change to intradermal (ID) delivery with DSJIs for hepatitis B and yellow fever vaccines, while the other vaccines are delivered by DSJIs at current dose and depth. The main advantage of ID delivery is that only a small fraction of the standard dose may be needed to obtain an immune response similar to that of subcutaneous or intramuscular injection. Cost categories included were vaccines, injection equipment, waste management, and vaccine transport. Some delivery cost items, such as training and personnel were excluded as were treatment cost savings caused by a reduction in diseases transmitted due to unsafe injections. RESULTS: In the standard dose and depth scenario, the incremental costs of introducing DSJIs per fully vaccinated child amount to US$ 0.57 in Brazil, US$ 0.65 in India and US$ 1.24 in South Africa. In the ID scenario, there are cost savings of US$ 0.11 per child in Brazil, and added costs of US$ 0.45 and US$ 0.76 per child in India and South Africa, respectively. The most important incremental cost item is jet injector disposable syringes. CONCLUSION: The incremental costs should be evaluated against other vaccine delivery technologies that can deliver the same benefits to patients, health care workers, and the community. DSJIs deserve consideration by global and national decision-makers as a means to expand access to ID delivery and to enhance safety at marginal additional cost.

Randomized controlled clinical trial of fractional doses of inactivated poliovirus vaccine administered intradermally by needle-free device in Cuba.

BACKGROUND: As part of an evaluation of strategies to make inactivated poliovirus vaccine (IPV) affordable for developing countries, we conducted a clinical trial of fractional doses of IPV in Cuba. METHODS: We compared the immunogenicity and reactogenicity of fractional-dose IPV (0.1 mL, or 1/5 of a full dose) given intradermally using a needle-free jet injector device compared with full doses given intramuscularly. Subjects were randomized at birth to receive IPV at 6, 10, and 14 weeks. RESULTS: A total of 471 subjects were randomized to the 2 study groups, and 364 subjects fulfilled the study requirements. No significant differences at baseline were detected. Thirty days after completing the 3-dose schedule of IPV, 52.9%, 85.0%, and 69.0% of subjects in the fractional-dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively, whereas 89.3%, 95.5%, and 98.9% of subjects in the full-dose IPV arm seroconverted for poliovirus types 1, 2, and 3, respectively (all comparisons, P < .001). The median titers of each poliovirus serotype were significantly lower in the intradermal arm than in the intramuscular arm (P < .001). Only minor local adverse effects and no moderate or serious adverse events were reported. CONCLUSIONS: This large-scale evaluation demonstrates the feasibility of fractional doses of IPV given intradermally as an antigen-sparing strategy but also shows that IPV given to infants at 6, 10, and 14 weeks of age results in suboptimal immunogenicity (especially for the fractional-dose arm).

Avaliaçäo da resistência ao cisalhamento em dentina de cimentos de ionômero de vidro convencional e modificado e duas resinas compostas, empregando-se três sistemas adesivos e duas técnicas de secagem da dentina / Evaluate the shear bond strength on dentine of conventional and modified glass ionomer cements, with the use of three adhesive systems and two drying techniques

A influência de adesivos e da umidade dentinária na resistência ao cisalhamento da uniäo entre dentina e materiais restauradores diretos foi avaliada neste trabalho. Os materiais restauradores testados foram: um cimento de ionômero de vidro convencional (Chelon-fil - ESPE), um cimento de ionômero de vidro modificado com resina (Vitremer - 3M), uma resina composta modificada com poliácidos (Dyract - Dentsply) e uma resina composta (TPH Dentsply). No trabalho foram utilizados 240 pré-molares e molares humanos extraídos, que tiveram uma de suas superfícies proximais desgastadas até se obter uma superfície plana em dentina, sobre a qual foram aplicados os sistemas adesivos e os materiais restauradores. Os espécimes foram divididos em 4 grupos experimentais. No grupo 4.3.1, a dentina foi condiconada com o adesivo próprio indicado pelo fabricante do material restaurador; no grupo 4.3.2., a dentina foi condicionada com um sistema adesivo experimental Gluma C; no grupo 4.3.3, a dentina foi condicionada com o sistema adesivo Prime & Bond 2.0 (Dentsply); e no grupo 4.3.4, a dentina foi condicionada com o sistema adesivo Scotchbond MP (3M). A técnica de secagem da dentina utilizada foi jato de ar por 5 segundos, considerada técnica seca, e lenço de papel aplicado duas vezes sobre a dentina, considerada técnica úmida. Os espécimes foram confeccionados com os materiais restauradores e os sistemas adesivos utilizados de acordo com as instruçöes dos fabricantes, armazenados em água por 24 horas e testados em máquina universal de testes KRATOS. A análise estatística mostrou que a resina composta Dyract, a melhor combinaçäo foi a do adesivo próprio na técnica úmida, que apresentou o maior resultado, de 23,36MPa. Os resultados com cimento Vitremer, utilizando-se os sistemas adesivos Prime & Bond 2.0 e o adesivo experimental Gluma C, foram de 16,45MPa e 13,58 MPa, respectivamente. Esses adesivos melhoraram significantemente a adesäo quando comparados com o adesivo próprio. Com relaçäo à técnica de secagem da dentina, a técnica úmida foi significantemente melhor que a técnica seca (p<0,01)

The efficacy and acceptability of using a jet injector in performing digital blocks.

This prospective, nonblinded study, comparing jet injection with needle-syringe injection of lidocaine in performing digital blocks, tested the hypothesis that jet injection can be used effectively as a less painful way to perform digital blocks. Twenty-four adult patients with injuries of the middle or distal phalanges of the fingers received digital blocks using a jet injector on one side of the finger and a needle-syringe on the other side; pain was assessed at 0, 1, 3, 6, 12, and 24 hours using visual analog scales. Differences in pain scores for the two procedures (jet injector vs needle) were tested at each time period using nonparametric statistical procedures for paired or matched data (paired Wilcoxon). At the time of injection (time 0) and at 12 hours, the jet had a significantly lower pain score than the needle. Comparisons made at the other points were statistically nonsignificant at .05. The anesthesia achieved using the jet injector was considered adequate in 23 of 24 patients. We conclude that the jet injector can be used effectively in performing digital blocks and is less painful than standard needle-syringe methods.