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Paediatrics
Protocol
External cold and vibration for pain management of children undergoing needle-related procedures in the emergency department: a randomised controlled non-inferiority trial protocol
  1. Ariane Ballard1,2,
  2. Christelle Khadra1,2,
  3. Samara Adler3,
  4. Evelyne D Trottier4,
  5. Benoit Bailey4,
  6. Naveen Poonai5,6,7,
  7. Jean Théroux8,
  8. Sylvie Le May1,2
  1. 1 Faculty of Nursing, University of Montreal, Montreal, Quebec, Canada
  2. 2 CHU Sainte-Justine Research Centre, Montreal, Quebec, Canada
  3. 3 Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada
  4. 4 Division of Emergency Medicine, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada
  5. 5 Department of Emergency Medicine, London Health Sciences Centre, London, Ontario, Canada
  6. 6 Department of Pediatrics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada
  7. 7 Children’s Health Research Institute, London Health Sciences Centre, London, Ontario, Canada
  8. 8 School of Health Professions, Murdoch University, Murdoch, Western Australia, Australia
  1. Correspondence to Ariane Ballard; ariane.ballard{at}hotmail.com

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.

  • buzzy
  • topical anesthetic
  • pain management
  • children
  • non-pharmacological intervention

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2018-023214

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    Footnotes

    • Contributors AB conceptualised and designed the study and wrote the first draft of this research protocol. CK, EDT, BB, NP, JT and SL provided feedback to refine the research methodology. SA, EDT and BB contributed to the implementation of the study. SA is involved in the data collection process. All authors read, critically revised and approved the final version of this research protocol.

    • Funding This work is supported by funds from the Quebec Network on Nursing Intervention Research.

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval Research Ethics Board (REB) of the CHU Sainte-Justine (# 2017-1405).

    • Provenance and peer review Not commissioned; externally peer reviewed.