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

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 paed iatric 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 tha t 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 day s 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 re...
Source: Trials - Category: Research Source Type: clinical trials