Dataset Information

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

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. 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.

SUBMITTER: Ballard A

PROVIDER: S-EPMC6340451 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Ballard Ariane A Khadra Christelle C Adler Samara S D Trottier Evelyne E Bailey Benoit B Poonai Naveen N Théroux Jean J Le May Sylvie S

BMJ open 20190115 1

<h4>Introduction</h4>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 a ...[more]

PMID: 30782698

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Project description:ObjectivesTo examine (1) the effectiveness of therapeutic play in reducing anxiety and negative emotional manifestations among children undergoing cast-removal procedures and (2) the satisfaction of parents and cast technicians with cast-removal procedures.DesignA randomised controlled trial.SettingAn orthopaedic outpatient department of a regional teaching hospital in Hong Kong.ParticipantsChildren (n=208) aged 3-12 undergoing cast-removal procedure were invited to participate.InterventionsEligible children were randomly allocated to either the intervention (n=103) or control group (n=105) and stratified by the two age groups (3-7 and 8-12 years). The intervention group received therapeutic play intervention, whereas the control group received standard care only. Participants were assessed on three occasions: before, during and after completion of the cast-removal procedure.Outcome measuresChildren's anxiety level, emotional manifestation and heart rate. The satisfaction ratings of parents and cast technicians with respect to therapeutic play intervention were also examined.ResultsFindings suggested that therapeutic play assists children aged 3-7 to reduce anxiety levels with mean differences between the intervention and control group was -20.1 (95% CI -35.3 to -4.9; p=0.01). Overall, children (aged 3-7 and 8-12) in the intervention groups exhibited fewer negative emotional manifestations than the control group with a mean score difference -2.2 (95% CI -3.1 to -1.4; p<0.001). Parents and technicians in the intervention group also reported a higher level of satisfaction with the procedures than the control group with a mean score difference of 4.0 (95% CI -5.6 to 2.3; p<0.001) and 2.6 (95% CI 3.7 to 1.6; p<0.001), respectively.ConclusionTherapeutic play effectively reduces anxiety and negative emotional manifestations among children undergoing cast-removal procedures. The findings highlight the importance of integrating therapeutic play into standard care, in particular for children in younger age.Trial registration numberChiCTR-IOR-15006822; Pre-results.

Project description:ObjectivesEmergency department (ED) crowding is an increasing problem associated with adverse patient outcomes. ED expansion is one method advocated to reduce ED crowding. The objective of this analysis was to determine the effect of ED expansion on measures of ED crowding.MethodsThis was a retrospective study using administrative data from two 11-month periods before and after the expansion of an ED from 33 to 53 adult beds in an academic medical center. ED volume, staffing, and hospital admission and occupancy data were obtained either from the electronic health record (EHR) or from administrative records. The primary outcome was the rate of patients who left without being treated (LWBT), and the secondary outcome was total ED boarding time for admitted patients. A multivariable robust linear regression model was used to determine whether ED expansion was associated with the outcome measures.ResultsThe mean (±SD) daily adult volume was 128 (±14) patients before expansion and 145 (±17) patients after. The percentage of patients who LWBT was unchanged: 9.0% before expansion versus 8.3% after expansion (difference = 0.6%, 95% confidence interval [CI] = -0.16% to 1.4%). Total ED boarding time increased from 160 to 180 hours/day (difference = 20 hours, 95% CI = 8 to 32 hours). After daily ED volume, low-acuity area volume, daily wait time, daily boarding hours, and nurse staffing were adjusted for, the percentage of patients who LWBT was not independently associated with ED expansion (p = 0.053). After ED admissions, ED intensive care unit (ICU) admissions, elective surgical admissions, hospital occupancy rate, ICU occupancy rate, and number of operational ICU beds were adjusted for, the increase in ED boarding hours was independently associated with the ED expansion (p = 0.005).ConclusionsAn increase in ED bed capacity was associated with no significant change in the percentage of patients who LWBT, but had an unintended consequence of an increase in ED boarding hours. ED expansion alone does not appear to be an adequate solution to ED crowding.

Dataset Information

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

Publications

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

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