Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial

Holbert, Maleea D. and Griffin, Bronwyn R. and McPhail, Steven M. and Ware, Robert S. and Foster, Kelly and Bertoni, Demi C. and Kimble, Roy M. (2019) Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: study protocol for a randomised controlled trial. Trials, 20 (1 - Article 13).

[img]
Preview
Text (Published Version)
Burns Paper (002).pdf
Available under License Creative Commons Attribution 4.0.

Download (1152Kb) | Preview

Abstract

Background: Burns are a painful and traumatic experience, particularly in children. Reduced pain and anxiety positively influences re-epithelialisation rates in paediatric burn patients, however current literature fails to fully explain the effects of pain and anxiety and their links with wound healing. This study will determine if Burnaid® hydrogel dressing is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain will then improve re-epithelialisation time in comparison to plastic wrap, which is standard practice at our institution — a metropolitan tertiary paediatric hospital located in Brisbane, Australia.

Methods/design: A randomised controlled trial will be conducted to assess the effectiveness of Burnaid® as an analgesic adjunct to cold running water first aid for the treatment of paediatric burns. Participants will include children aged between 0 and 16years with an acute thermal burn injury (total burn surface area <20%) presenting to the Department of Emergency within 24h of the burn occurring. Participants will be randomised into one of two groups: (1) Burnaid® hydrogel (intervention arm) or (2) plastic wrap (control arm). Participants will also be stratified into one of two groups based on factors that influence pain intensity: (1) high pain risk or (2) low pain risk. High pain risk factors include foot burns, hot coal/ash/fire pit burns, burn area greater than 5%, and circumferential burns. The primary outcome is the intervention’s effect on reducing acute pain. Secondary outcomes include days to re-epithelialisation, pulse rate, temperature, salivary cortisol and α-amylase, anxiety, and cost-effectiveness. Sample size calculations have shown that 36 participants will be recruited into each group.

Discussion: This study will provide comprehensive data on the analgesic properties of Burnaid® as an adjunct to first aid for the treatment of acute paediatric thermal burns. If the intervention is effective in reducing pain, Burnaid® will be integrated as standard practice within the hospital’s Department of Emergency. This study replicates a real-world scenario in order to identify clinically significant analgesic and wound-healing effects.

Trial registration: Australian New Zealand Clinical Trials Registry, ACTRN12617001274369. Prospectively registered on 5 Sept 2017.


Statistics for USQ ePrint 35743
Statistics for this ePrint Item
Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: Published version made available under the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license.
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Nursing and Midwifery
Date Deposited: 21 Mar 2019 00:33
Last Modified: 30 May 2019 04:53
Uncontrolled Keywords: paediatric, burns, first aid, hydrogel, Burnaid®, re-epithelialisation, analgesia, dressing, randomised controlled trial, pain
Fields of Research : 11 Medical and Health Sciences > 1114 Paediatrics and Reproductive Medicine > 111403 Paediatrics
Identification Number or DOI: 10.1186/s13063-018-3057-x
URI: http://eprints.usq.edu.au/id/eprint/35743

Actions (login required)

View Item Archive Repository Staff Only