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

Abstract

BackgroundBurns 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/designA 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 16 years with an acute thermal burn injury (total burn surface area < 20%) presenting to the Department of Emergency within 24 h 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.DiscussionThis 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 registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001274369. Prospectively registered on 5 Sept 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3057-x) contains supplementary material, which is available to authorized users.

Can hydrogel dressings reduce patients' discomfort and side effects of facial platelet‐rich plasma injections?

“…9 The literature indicates that cooled hydrogel dressings reduce pain when applied on wounds. 10 During PRP therapy, we performed approximately 30 to 50 small injections lacerating a large surface of the facial skin. This led to needle prick-induced pain despite previous application of numbing cream.…”

“…Several forms, including solid sheets or semi‐liquid gels are available 9 . The literature indicates that cooled hydrogel dressings reduce pain when applied on wounds 10 . During PRP therapy, we performed approximately 30 to 50 small injections lacerating a large surface of the facial skin.…”

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

“…Study methodology was documented in a published protocol 18 and registered with the Australian New Zealand Clinical Trials Registry (ID number: ACTRN12617001274369) on the 5 September 2017 prior to recruitment. This trial was completed as per the published protocol, 18 which contains a more in-depth description of the trial’s design and methods.…”

Development of 3D Printed Drug-Eluting Scaffolds for Preventing Piercing Infection

“…It has been reported that a treatment delay greater than five days for cartilage infections can lead to severe outcomes, such as impaired hearing, ear deformation, and amputation of the auricle [ 10 ]. There has been much effort to prevent infection resulting from wounds by administering a wide range of active agents to the wound locally: these agents include anti-infective [ 12 , 13 , 14 ], anti-inflammatory [ 15 , 16 , 17 ], and analgesic [ 18 , 19 , 20 ] compounds. The common aftercare practice for preventing ear piercing infection is the regular application of antiseptics or antibiotics [ 18 , 21 , 22 , 23 , 24 ] for a few weeks, which is not thoroughly effective as nearly 20% of all piercings lead to local infection [ 6 ].…”