Efficacité d’un dispositif combinant le froid et la vibration pour la gestion de la douleur d’enfants lors de procédures impliquant des aiguilles dans les services d’urgence : un essai clinique randomisé de non-infériorité

Les procédures impliquant des aiguilles sont la plus importante source de douleur chez les enfants. Considérant qu’il est impossible d’éliminer complètement la douleur ressentie lors de procédures douloureuses, il est de la responsabilité professionnelle de l’infirmière d’assurer sa gestion à l’aide d’interventions non-pharmacologiques et/ou pharmacologiques. Les interventions actuellement disponibles pour le soulagement de la douleur procédurale des enfants nécessitent beaucoup de temps ou de personnel, ce qui représente des barrières à leur implantation dans les services d’urgence. Par conséquent, l’utilisation d’une intervention non-pharmacologique rapide et facile d’utilisation pourrait permettre de pallier ces contraintes. À cet effet, un dispositif combinant le froid et la vibration (Buzzy) a été développé dans l’objectif d’optimiser le soulagement de la douleur procédurale pédiatrique. Ce dernier repose sur deux mécanismes permettant la modulation du message douloureux, soit la théorie du portillon et les contrôles inhibiteurs nociceptif diffus. Le dispositif Buzzy semble donc être une avenue prometteuse pour surmonter les obstacles reliés à la gestion de la douleur lors de procédures impliquant des aiguilles dans les services d’urgence. Le but principal de cette étude était de déterminer si un dispositif combinant le froid et la vibration (dispositif Buzzy) était considéré comme étant non-inférieur à un anesthésique topique (lidocaïne liposomale 4%) pour la gestion de la douleur d’enfants lors de procédures impliquant des aiguilles dans les services d’urgence. Cet essai clinique randomisé de non-infériorité parallèle à deux groupes a été mené dans le service d’urgence d’un centre hospitalier universitaire pédiatrique (CHU Sainte-Justine, Montréal, Canada). Un total de 352 enfants âgés entre 4 et 17 ans a été recruté et 346 ont été randomisés, soit au groupe expérimental (dispositif Buzzy=172) ou au groupe contrôle (anesthésique topique=174). Pour les participants ayant été assignés au groupe expérimental, le dispositif Buzzy a été appliqué à environ 5 cm au-dessus du site d’insertion et a été maintenu en place tout au long de la procédure. Pour les participants ayant été assignés au groupe contrôle, un anesthésique topique (lidocaïne liposomale 4%) a été appliqué au niveau du site d’insertion 30 minutes avant la procédure. Selon l’analyse en intention de traiter, la différence moyenne de douleur procédurale entre les deux groupes à l’étude (dispositif Buzzy : 3,92 3,13; anesthésique topique : 3,27 3,02) était de 0,64 (95%IC -0,10 à 1,26) sur l’échelle de mesure Color Analogue Scale (0-10). Ceci démontre donc que le dispositif Buzzy n’est pas considéré comme étant non-inférieur à l’anesthésique topique. En ce qui concerne la détresse procédurale, aucune différence statistiquement significative n’a été décelée avec les deux échelles de mesures utilisées (Procedure Behavior Check List : p=0,104 ; Children’s Fear Scale : p=0,421). Il n’y avait également aucune différence statistiquement significative en ce qui concerne le succès de la procédure au premier essai (p=0,489) ainsi que la mémoire de la douleur 24 heures après la procédure (p=0,346). De plus, aucun effet secondaire n’a été enregistré pour les participants ayant utilisé le dispositif Buzzy et seulement un évènement est survenu chez un participant ayant reçu l’anesthésique topique. Enfin, les parents des deux groupes ont rapporté être satisfaits avec l’intervention reçu par leur enfant (p=0,257) et la majorité des infirmières (65,0%) ont manifesté une préférence pour le dispositif Buzzy. Le dispositif Buzzy n’est pas considéré comme étant non-inférieur à un anesthésique topique pour la gestion de la douleur d’enfants lors de procédures impliquant des aiguilles. Toutefois, considérant que les anesthésiques topiques sont sous-utilisés dans les services d’urgence, le dispositif Buzzy représente une alternative intéressante à cette méthode pharmacologique nécessitant un temps d’application. Par conséquent, le dispositif Buzzy pourrait être davantage transférable à la pratique et les cliniciens pourraient possiblement l’intégrer plus facilement dans leur routine quotidienne.Needle-related procedures are considered as the most important source of pain in children in hospital settings. It is now recognized that even minor procedures can result in physiological, psychological and emotional consequences. For these reasons, management of children’s pain and distress through pharmacological and/or non-pharmacological intervention is essential. Healthcare professionals working in the Emergency Department (ED) setting face particular challenges regarding procedural pain management related to their work environment. Time constraints, heavy workload, and busy environment represent barriers to the use of available interventions for pain management during needle-related procedures. Therefore, the use of a rapid, easy-to-use intervention could improve procedural pain management practices in the context of the ED. As such, the Buzzy device, which is a bee-shaped device combining vibration and cold, seems to be a promising alternative. The theoretical bases of this device are the Gate Control Theory and the diffuse noxious inhibitory controls, both generating the modulation of pain. The primary objective of this study was to determine if a device combining cold and vibration (Buzzy device) was considered as non-inferior (no worse) to a topical anesthetic (liposomal lidocaine 4% cream) for pain management in children undergoing needle-related procedures in the ED. This randomized, controlled, non-inferiority trial with two parallel groups was conducted in the ED of a university pediatric tertiary hospital center (CHU Sainte-Justine, Montreal, Canada). A total of 352 participants were enrolled and 346 were randomized to either experimental (Buzzy device=172) or control (topical anesthetic=174) groups. For the participants allocated to the experimental, the Buzzy device was applied 5 cm above the insertion site group just before the needle-related procedure and was maintained in place throughout the procedure. For the participants allocated to the control group, a topical anesthetic cream (liposomal lidocaine 4%) was applied at the insertion site 30 minute before the needle-related procedure. Using an intention-to-treat analysis, the mean difference in procedural pain scores between the experimental group (3,92 3,13) and the control group (3,27 3,02) was 0.64 (95%CI -0,10 to 1,26) using the Color Analogue Scale, showing that the Buzzy device was not non-inferior to the topical anesthetic. Regarding the procedural distress, no significant difference was found between groups using the both measuring scales (Procedure Behavior Check List: p=0,104; Children’s Fear Scale: p=0,421). In addition, no significant difference was also found between groups regarding the success of the procedure at first attempt (p=0,489) and the memory for pain 24 hours after the procedure (p=0,346). Parents of both groups were satisfied with the received interventions (p=0,257) and the majority of nurses (65,0%) preferred the Buzzy device over the topical anesthetic. No adverse events occurred in the cold and vibrating group and one adverse event was reported in the topical anesthetic cream group. The non-inferiority of the cold and vibrating device over a topical anesthetic was not demonstrated for pain management of children during needle-related procedure in the ED. However, considering that topical anesthetics are underused in the ED setting, the Buzzy device seems to be a promising alternative as it is a rapid, low-cost, easy-to-use and reusable intervention. Consequently, it could be more likely to be translated into clinical practice and adopted by clinicians for routine use

External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol.

INTRODUCTION: Needle-related procedures are considered as the most important source of pain and distress in children in hospital settings. Considering the physiological and psychological consequences that could result from these procedures, management of pain and distress through pharmacological and non-pharmacological methods is essential. Therefore, it is important to have interventions that are rapid, easy-to-use and likely to be translated into clinical practice for routine use. The aim of this study will be to determine whether a device combining cold and vibration (Buzzy) is non-inferior to a topical anaesthetic (liposomal lidocaine 4% cream) for pain management of children undergoing needle-related procedures in the emergency department. METHODS AND ANALYSIS: This study will be a randomised controlled non-inferiority trial comparing the Buzzy device to liposomal lidocaine 4% cream for needle-related pain management. A total of 346 participants will be randomly assigned in a 1:1 ratio to one of the two study groups. The primary outcome will be the mean difference in pain intensity between groups during needle-related procedures. A non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. A Non-inferiority margin of 0.70 on the Color Analogue Scale will be considered. The secondary outcomes will be the level of distress during the procedure, the success of the procedure at first attempt, the occurrence of adverse events, the satisfaction of both interventions and the memory of pain 24 hours after the procedure. The primary outcome will be assessed for non-inferiority and the secondary outcomes for superiority. ETHICS AND DISSEMINATION: This study protocol was reviewed and approved by the institutional review board of the study setting. Findings of this trial will be disseminated via peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT02616419

AVALIAÇÃO DAS CARACTERÍSTICAS SENSORIAIS E FÍSICO-QUÍMICAS DE IOGURTE ADICIONADO DE INULINA

O estudo teve como objetivo verificar a aceitabilidade sensorial de iogurtes adicionados de inulina e determinar a composição físico-química da formulação tradicional e daquela contendo o maior teor da fibra com aceitação sensorial semelhante a padrão. Foram elaboradas cinco formulações de iogurtes sendo: padrão (F1) e as demais com de 2,50% (F2), 5,00% (F3), 7,50% (F4) e 8,80% (F5) adicionadas de inulina. Participaram da análise sensorial 118 provadores não treinados, de ambos os gêneros, com idade entre 18 a 48 anos. Os resultados da análise sensorial mostraram que a amostra com adição de 2,50% de inulina foi aquela com o maior teor e com aceitação semelhante à padrão, principalmente no atributo sabor, aceitação global e intenção de compra. A análise físico-química das amostras padrão e com 2,50% de inulina revelou menores teores de calorias e maior teor de fibra alimentar. A elaboração dos produtos permitiu comprovar que um nível de adição de até 2,50% de inulina em iogurtes foi bem aceito pelos provadores, obtendo-se aceitação sensorial semelhante ao produto padrão e com boas expectativas de comercialização

Processus décisionnel du consentement aux soins chez l’adolescent atteint d’un cancer : une perspective triadique

Introduction. Le processus décisionnel du consentement aux soins en oncologie pédiatrique est reconnu comme un processus complexe étant donné que plusieurs acteurs y interviennent. Au Québec, ce processus est d’autant plus complexe qu’il implique un enjeu légal, soit qu’un adolescent âgé de 14 ans et plus peut, sous certaines conditions, donner son consentement aux soins sans obtenir l’autorisation parentale. Objectif. La présente recherche avait pour but de modéliser le processus décisionnel dans une perspective triadique incluant l’adolescent, les parents et les infirmières pivots. Méthode. Les données ont été recueillies grâce à des entrevues individuelles semi-structurées et des questionnaires sociodémographiques. Les entrevues ont été transcrites et analysées à l’aide du logiciel d’analyse qualitative QDA Miner selon la méthodologie de la théorisation ancrée de Corbin et Strauss. Résultats. Les résultats dévoilent que la triade décisionnelle est un phénomène existant en oncologie pédiatrique. Cependant, le poids de chacun des acteurs dans le processus décisionnel varie selon différentes conditions préalables au processus. Discussion et conclusion. Les résultats démontrent que les infirmières ont un rôle à jouer dans le processus décisionnel et qu’il importe de sensibiliser davantage les différents acteurs afin d’atténuer certaines barrières et pour faciliter l’intégration des adolescents dans le processus.Introduction. Obtaining consent to care in pediatric oncology is recognized as a complex decisional process on account of the multiple stakeholders involved. In Quebec, the process is complicated all the more by the fact that teenagers 14 years and over can, under certain circumstances, consent to care without parental approval. Objective. The aim of this study was to develop a conceptual model of the decisional process involved in obtaining consent to care for adolescents with cancer from the triadic perspective of adolescents, parents and pivot nurses. Method. Data were collected through individual semi-structured interviews and sociodemographic questionnaires. Interviews were transcribed and analyzed with the QDA Miner qualitative analysis software following the grounded theory approach proposed by Corbin and Strauss. Results. Results revealed the decisional triad to be a real phenomenon in pediatric oncology. However, the weight of each stakeholder in the decisional process varied according to conditions preceding the process. Discussion and conclusion. Results show that nurses have a role to play in the decisional process and that it is important to sensitize the stakeholders in order to lower certain barriers and make it easier to include the adolescents in the process

Efficacy of the Buzzy® device for pain management of children during needle-related procedures: a systematic review protocol

Abstract Background Needle-related procedures are the most important source of pain in children in hospital setting. Unmanaged pain could result in short- and long-term physiological, psychological, and emotional consequences. Although the efficacy of numerous interventions has been evaluated, procedural pain management is often suboptimal in children undergoing needle-related procedures. The main objective of this systematic review is to examine the evidence for the efficacy of the Buzzy® device for needle-related procedural pain in children. Methods An electronic search will be conducted in the following databases: CENTRAL, PubMed, MEDLINE, EMBASE, PsycInfo, and CINAHL. There will be no restriction regarding the language, date of publication, and publication status. Eligible studies will be randomized controlled trials using the Buzzy® device for pain management in children undergoing needle-related procedures. Selection of studies, data extraction and management, assessment of risk of bias and quality of evidence will be performed by two independent reviewers. A third researcher will be consulted in case of discrepancies. Depending on the availability and quality of the data as well as clinical and statistical heterogeneity, a meta-analysis will be performed. Otherwise, findings will be qualitatively reported. Discussion This will be the first systematic review to examine the efficacy of the Buzzy® device on pain management of children during needle-related procedures. Results of this review will guide clinical practice and recommendations for further research to improve procedural pediatric pain management. Systematic review registration PROSPERO CRD4201707653

Systematic review and meta-analysis of olfactive stimulation interventions to manage procedural pain in preterm and full-term neonates

Background Preterm and full-term neonates undergo many painful procedures during their hospitalization in the neonatal intensive care unit. Unrelieved and repeated pain can have important repercussions on their motor and intellectual development. Still, pain management interventions are limited for neonates. Objective This systematic review aimed to evaluate the effectiveness of olfactive stimulation interventions on the pain response of preterm and full-term infants during painful procedures. Design Systematic review and meta-analysis. Data sources An electronic search was conducted from inception to August 2019 in PubMed, MEDLINE, Embase, CINAHL, PsycINFO, Web of Sciences, CENTRAL, Scopus and ProQuest. Review methods Study selection, data extraction, assessment of risk of bias and quality of evidence were performed by two independent reviewers. Results 3311 studies were screened. Of the 14 studies included studies (n = 1028 infants), results from 10 were combined in meta-analysis. The latter demonstrated that olfactive stimulation interventions using a familiar odor were effective compared to standard care on pain reactivity (SMD -0.69; 95% CI -0.93 to -0.44; I2 = 20%, p < 0.00001), pain regulation (SMD -0.40; 95% CI -0.66 to -0.14; I2 = 13%, p = 0.002), crying duration during (SMD -0.42; 95% CI -0.73 to -0.10; I2 = 47%, p = 0.009) and after the procedure (SMD -0.37; 95% CI -0.68 to -0.07; I2 = 0%, p = 0.01), heart rate after the procedure (MD -3.87; 95% CI -7.36 to -0.38; I2 = 99%, p = 0.03), oxygen saturation during (MD -0.47; 95% CI -0.86 to -0.08; I2 = 91%, p = 0.02) and after the procedure (MD -0.56; 95% CI -0.99 to -0.13; I2 = 99%, p = 0.01). No adverse event was reported. Conclusion These findings are based on low to very low quality of evidence limiting our confidence in effect estimates. More rigorous trials with a larger sample size are needed to enhance the comprehension of the mechanisms underlying olfactive stimulation interventions and the interventions’ efficacy

Développement et validation de l’Échelle d’Observation Comportementale du Confort d’Enfants Brûlés (OCCEB-BECCO)

Introduction. Les soins des brûlures chez les enfants occasionnent beaucoup de douleur et d’appréhension. Le confort, un concept référant autant à l’absence de douleur physique qu’au bien-être, est important pour évaluer la qualité des soins prodigués par les infirmières aux jeunes enfants brûlés. À notre connaissance, aucun instrument n’existe actuellement pour mesurer le confort lors de procédures douloureuses chez les enfants ayant subi des brûlures. Objectif. Développer et valider une échelle de mesure du confort, lors de procédures douloureuses, chez les jeunes enfants ayant subi des brûlures. Méthodes. Une revue de la littérature a permis de générer 38 énoncés dont le nombre a été réduit à 14 par un panel composé de 13 professionnels de la santé. Les énoncés ont été ensuite regroupés sous quatre sous-échelles comportementales principales : visage, pleurs, mouvements et attitude. L’instrument développé (OCCEB-BECCO) a été ensuite pré-testé auprès de 16 enfants âgés de moins de 5 ans ayant subi des brûlures. Résultats. L’instrument était clair, concis et simple à utiliser selon les experts. L’alpha de Cronbach était de 0,82. La corrélation était élevée entre l’OCCEB-BECCO et l’échelle Face Legs Activity Cry Consolability (FLACC) (r≥0,95) à tous les temps de mesure. Discussion et conclusion. L’OCCEB-BECCO, première échelle visant à évaluer le confort d’enfants brûlés lors de procédures douloureuses, est une mesure fiable et valide. Cependant, d’autres études devront être effectuées, auprès de plus grands échantillons, pour compléter la validation de l’échelle.Introduction. Burn care causes children a great deal of pain and apprehension. Comfort, a concept referring as much to the absence of physical pain as to well-being, is a key consideration in assessing the quality of nursing care provided to young burn victims. However, no instrument existed to measure level of comfort of child burn victims during the delivery of painful care procedures. Objective. To develop and validate a scale to measure the comfort level of young child burn victims subjected to painful care procedures. Methods. Following a review of the literature, 38 items were generated to measure comfort in this context. These were reduced to 14 by a panel of 13 healthcare professionals. The items were then grouped under four main headings: face, cry, movement, and attitude. Finally, the new instrument (OCCEB-BECCO) was pre-tested on 16 burn victims under the age of 5. Results. Experts found the instrument to be clear, concise and easy to use. Cronbach’s alpha was 0.82. The correlation between the OCCEB-BECCO and the Face Legs Activity Cry Consolability (FLACC) scale was high (r≥0.95) at all times of measurement. Discussion and conclusion. The first scale of its kind, the OCCEB-BECCO is a reliable and valid measure of the comfort level of young child burn victims during painful procedures. However, more research is needed with larger samples to complete the scale’s validation

Additional file 1: of Efficacy of the BuzzyÂŽ device for pain management of children during needle-related procedures: a systematic review protocol

Draft of the search strategy and terms used for one of the databases. (DOCX 133 kb

Développement et validation de la version canadienne-française de l’échelle de Satisfaction des Adolescents de la gestion de la Douleur postopératoire – Scoliose idiopathique (SAD-S)

<p><b>Background</b>: Spinal fusion for scoliosis generates moderate to severe pain intensity. There are currently no instruments available to measure adolescents’ satisfaction regarding post-spinal fusion pain management.</p> <p><b>Aims</b>: To develop and validate a scale on satisfaction of adolescents regarding pain management following spinal fusion for scoliosis.</p> <p><b>Methods</b>: A methodological design was used to develop and validate the French-Canadian scale “Satisfaction des Adolescents de la gestion de la Douleur postopératoire – Scoliose idiopathique (SAD-S)”. A modified Delphi method, with seven healthcare professionals and 10 adolescents, was used to establish content validity of the SAD-S. A pre-test of the scale was conducted with 10 adolescents post-spinal fusion. The final version of the scale was validated through a pilot study with 98 adolescents following their surgery.</p> <p><b>Results</b>: The SAD-S scale includes a total of 13 items. Principal component analysis yielded a two-factor structure (2 subscales): 1) Pain management education and 2) Education regarding medication. These two factors explained 47,8% of the total variance for satisfaction. A Cronbach’s alpha of 0,84 was obtained for internal consistency.</p> <p><b>Conclusion</b>: Validation of the SAD-S scale showed that it has good psychometric properties with this population. Further validation is required with a larger sample to pursue its validation.</p