Abstract 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. A total of participants will be randomly assigned in a ratio to one of the two study groups.
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Abstract 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. A total of participants will be randomly assigned in a 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. A Non-inferiority margin of 0.
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 Keywords: buzzy, topical anesthetic, pain management, children, non-pharmacological intervention Strengths and limitations of this study This is the first study to assess the efficacy of the Buzzy device in Canada.
The large sample size of participants will provide enough power to demonstrate the non-inferiority of the Buzzy device compared with a topical anaesthetic. The non-inferiority margin is justified on both clinical and statistical grounds.
This study presents potential clinical implications for nursing and medical practices in the emergency department. The main limitation of this trial is the impossibility to blind participants and personnel to intervention allocation. Introduction Background and rationale Needle-related procedures, such as venipunctures and intravenous catheter insertions, are considered as the most important source of pain and distress in children in hospital settings.
Consequently, children are at high risk for undertreatment of their pain during needle-related procedures. Among these, there are sweet-tasting solutions, 32 33 needle-free injection systems, 34 35 vapocoolant sprays 36 and distraction. The optimal intervention for needle-related procedural pain management in the ED would need to be rapid, easy-to-use and without side effects.
The Buzzy is a bee-shaped device combining vibration body of the bee and cold removable ice wings. To date, there have been some randomised controlled trials that have investigated the efficacy of the Buzzy device on pain management in children undergoing needle-related procedures in various medical settings.
Of those studies, only two have been conducted in the ED setting, 45 49 and none have been done in Canada. Improve the success of the needle-related procedure at first attempt. Decrease memory of pain 24 hours after the needle-related procedure. Other secondary objectives To determine the occurrence of adverse events in each study group. Method This study protocol was developed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials recommendations.
This study design is of interest when a new intervention seems to present some advantages over the reference intervention. As recommended for a non-inferiority trial, 51 a study demonstrating the superiority of the reference intervention compared with a placebo in a similar context should be used as rationale to support this study design.
Interventions Experimental group: Buzzy device Participants in the experimental group will receive the Buzzy device intervention.
The Buzzy is a palm-sized device with two components: 1 body of the bee vibration and 2 removable and reusable ice wings ice. The body of the bee is a vibrating motor powered by two alkaline AAA batteries, and it lasts for about 20 hours. The vibration component is activated by a manual switch on the top part of the device. The removable set of wings contain a total of 18 g of ice. Each set of ice wings can stay frozen for about 10 min at room temperature, and they are reusable up to times.
Enrolled children will have the opportunity to hold and get familiarised with the Buzzy device before the needle-related procedure. More specifically, the Gate Control Theory stipulates that the vibration component of the device blocks the A-delta and C nociceptive fibres by stimulating the A-beta non-nociceptive fibres. It activates an inhibitory interneuron and results in a reduction of the pain signal transmitted to the spinal cord. The topical anaesthetic cream and the Tegaderm dressing will be removed just before the procedure.
This intervention was chosen as an active control intervention as it has been shown to be the most effective for pain management regarding needle-related procedures, 23—26 and it is also the standard care currently established in the study setting.
Following the application, a temporary loss of sensation in the limited area of application is produced. Potentially eligible children will be initially assessed on arrival to the ED by triage nurses, staff nurses and physicians.
Informed written consent will be obtained from parents or legal guardians and assent will be obtained from children over 7 years old. Research nurses will maintain and complete a screening and enrolment log to provide a comprehensive list of all children who were screened for eligibility.
Data collection and outcomes measures Data collection will start following consent and enrolment. All data will be collected by one of the two research nurses using a paper case report form CRF developed and designed for this study. In addition to the primary and secondary outcomes, sociodemographic and clinical data and covariates will be recorded. Data will be collected at different end points: before randomisation T-0 , 5 min before the needle-related procedure T-1 , during the needle-related procedure T-2 , immediately after the needle-related procedure T-3 and 24 hours after the needle-related procedure T Of note, the needle-related procedure will be performed by the staff nurse and not the research nurse.
Sociodemographic and clinical data Before randomisation of participants T-0 , sociodemographic and clinical data will be collected by the research nurse. These data will include age, sex, reason for consultation, previous experience s of needle-related procedures and analgesia received in the last 4 hours prior the procedure.
Contact preference and information will also be obtained for a follow-up 24 hours after the needle-related procedure. Primary outcome measure The primary outcome will be the mean difference in pain scores during the needle-related procedure between groups. The meaning of each anchor will also be explained to the child prior to using the scale. The research nurse will record the corresponding pain score. Secondary outcomes measures The secondary outcomes will be the pain intensity during the needle-related procedure T-3 , the level of distress during the needle-related procedure T-2, T-3 , the success of the procedure at first attempt T-3 , the satisfaction with both interventions T-3 , the occurrence of adverse events and the memory of pain 24 hours after the needle-related procedure T Pain intensity Mean difference in procedural pain scores between groups will also be assessed using the Faces Pain Scales — Revised FPS-R 66 immediately after the first needle-related procedure attempt T This self-report pain scale is the revised version of the original scale previously developed by Bieri et al.
The research nurse will document the pain score associated with the face identified by the child. The PBCL is an observational scale specifically developed to evaluate pain-related fear and anxiety during painful procedures.
This scale consists of a checklist with eight behavioural items: muscle tension, screaming, crying, restraint used, pain verbalised, anxiety verbalised, verbal stalling and physical resistance. The CFS is a self-report scale developed to measure fear of children during painful experiences.
This scale has five faces with a range of scores from 0 to 4 as each face shows an increasing amount of being scared moving from left to right. If the procedure is not successful at first attempt, the research nurse will document the number of attempts in the CRF. An adverse event will be defined as an unexpected medical occurrence in a participant that may or may not be necessarily causally related to one of the two interventions.
Adverse events will be recorded after enrolment of the participant until hospital discharge. Memory of pain The memory of pain will be assessed by comparing pain scores between groups 24 hours after the needle-related procedure using the FPS-R phrased in terms of recall 66 T After the needle-related procedure, the research nurse will give a paper copy of the FPS-R to each parent or legal guardian with the corresponding instructions.
Covariates Data will be collected from participants and their parents for potential covariates. Data management All data collected with the CRFs will be manually entered into an electronic database statistical software, and the original CRFs will be kept on file at the participating site. Data entry and coding will be performed by the same person.
A verification will be done by a second person to compare with the original CRFs. Files will be maintained in storage for a period of minimum 25 years after completion of the study, according to Health Canada regulations for Health Canada Regulated Clinical Trials. The SAS software V. To ensure concealment, the block size will not be disclosed. The randomisation sequence will be stored at the URCA for the whole duration of the study in order to keep the investigators blinded from the study conditions.
The allocation concealment will be ensured by the use of sequentially numbered, opaque and sealed envelopes previously prepared by the URCA. After the enrolled participant will have completed all baseline measurements, the appropriate numbered envelope will be opened by the research nurse.
Each envelope will contain the randomisation number and the allocated intervention. To determine the non-inferiority margin, an electronic survey was sent to 34 paediatric emergency physicians working in ED settings from Quebec and Ontario.
Respondents had to choose a difference ranging from 0. The mean answer was 0. Considering that the minimal clinically significant difference on the CAS in children with acute pain is 1. We anticipate no loss to follow-up considering the short time frame between the intervention and the assessment of the primary outcome. Non-inferiority analysis will be evaluated according to the intention-to-treat principle primary analysis as well as to the per-protocol principle secondary analysis to examine for consistency and avoid bias.
Descriptive statistics will be used to report data collected on satisfaction, as well as sociodemographic and clinical data. Means and SD will be reported for continuous variables and proportions will be calculated for categorical and nominal variables. Potentially relevant preprocedural and procedural variables will be included in covariate model analysis of covariance in an attempt to determine predictors of pain scores reduction.
All secondary analysis will be carried out according to the intention-to-treat principle. Preplanned subgroups non-inferiority analyses will be carried out for the primary outcomes based on age group 4—7 years vs 8—12 years vs 13—17 years. As we will not have the statistical power in each subgroup to conclude to non-inferiority, the results will be considered as exploratory and will primarily serve for hypothesis generation for future studies.
Subgroups superiority analyses will be also performed by age group for secondary outcomes. Multiple imputation methods and sensitivity analysis will be used when possible and appropriate to handle the missing data. No formal interim analysis is planned for this non-inferiority trial for different reasons. First, there is no necessity to conduct interim analysis for futility reasons in non-inferiority trials considering that even if non-inferiority is established before the completion of the trial, the data collection should be pursued in hope of demonstrating superiority.
Discussion This study protocol provides the rationale and methods associated with a randomised controlled non-inferiority trial comparing the Buzzy device to a topical anaesthetic with the aim of improving procedural pain and distress management in children undergoing needle-related procedures.
To our knowledge, it will be the first study assessing the efficacy of the Buzzy device in Canada in any clinical setting. Therefore, this study has the potential to improve clinical care and outcomes of children undergoing needle-related procedures in the ED. In addition, this study could determine the efficacy of the Buzzy device intervention across age ranges and developmental differences.
Ethics: Theory and Practice
It does a good job of covering both the theoretical bases for ethics in the first half of the text and the current issues and areas of contention in ethics in the remaining portion of the text. The variety of ethical theories and the depth of discussion for critical topics makes this a first choice. Thiroux Dear Colleague, The importance of teaching ethics in higher education has never been greater. In our rapidly changing, globally expanding world, key challenges and problems revolve around fundamental issues in ethics. Leadership in such a world demands courage, commitment, character and good ethical reasoning skills to address these challenges head on. With the eleventh edition of Ethics: Theory and Practice I wish to acknowledge the significant contributions made by all involved in the teaching of ethics courses who engage students with the core issues of our time.
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Ethics : Theory and Practice