None listed
Conditions
Brief summary
1. Background Burns are a painful and traumatic experience. Literature has found that using pharmacological and non-pharmacological interventions aid in providing appropriate pain management and significantly improve paediatric burn outcomes. Overall, there seems to be some evidence that reduced pain and anxiety positively influences re-epithelialisation rates 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® is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain, as well as stress/anxiety, will then improve re-epithelialisation time in comparison to plastic wrap which is standard practice at our institute, a large metropolitan paediatric hospital located in Brisbane, Australia. 1.2 Methods/Design A randomised controlled trial will be conducted assessing the effectiveness of Burnaid® hydrogel dressings as an analgesic adjunct to cold running water (CRW) first aid for the treatment of paediatric burns. Participants will include children aged between 0 – 16 years with an acute thermal burn injury with a total burn surface area (TBSA) of < 20% admitted to our emergency within 24hours of the burn occurring. Participants will be stratified into one of two groups based on factors which increase pain intensity. The trial will then randomise patients into one of two groups: 1) Plastic wrap which will serve as the control arm or 2) Burnaid® which is the intervention arm. The trial requires a minimum of 29 participants per group, which will be assessed from day of injury to re-epithelialisation. The primary outcome of the trial is the effect of the intervention on reducing acute pain. Secondary outcomes include: days to re-epithelialisation, Physiological changes that indicate pain intensity (pulse rate, temperature and respiratory rate), analgesia and distraction techniques required, , cost effectiveness, staff perspectives on the treatmen, Health related Quality of Life (Child Health Utility 9D - CHU9D) and salivary cortisol and a-amylase ratio (informing influences of stress and anxiety) 1.3 Discussion This study will provide comprehensive data on the analgesic properties of Burnaid® hydrogel dressings as an adjunct to CRW first aid for the treatment of acute paediatric thermal burns. If the intervention shows to be effective in reducing acute pain, Burnaid® dressings will be integrated as standard care practices at our institute. This study replicates a real-world scenario in order to identify clinically significant analgesic and would healing effects.
Interventions
Burnaid® hydrogel dressing will be the chosen intervention that the child will receive based on randomisation on presentation to the Department of Emergency Medicine (DEM) or burns Outpatients Department (OPD). Burnaid® is a sterile open foamed polyester urethane foam that is impregnated with 90% purified water. The dressing has gained widespread use by paramedics in recent years in the treatment of acute burn pain.
In this study the Burnaid® dressing will be applied post 20 minutes Cold Runnin
Burnaid® hydrogel dressing will be the chosen intervention that the child will receive based on randomisation on presentation to the Department of Emergency Medicine (DEM) or burns Outpatients Department (OPD). Burnaid® is a sterile open foamed polyester urethane foam that is impregnated with 90% purified water. The dressing has gained widespread use by paramedics in recent years in the treatment of acute burn pain. In this study the Burnaid® dressing will be applied post 20 minutes Cold Running Water (CRW) and will remain on the burn for a minimum of 20 minutes. Burnaid® will be applied as per the manufactures instructions followed by standard burn care. The 20 min time period of Burnaid® hydrogel dressing has been selected in the acute phase of the burn where pain is still present after the 20 min of CRW has been completed. D After the Burnaid® has been removed, a standard, protocol informed, silver dressing will be applied. The silver dressing will remain intact until the patient is due to return to Burns OPD 3-7 days post injury. The silver dressing will be changed twice weekly, in the Burn OPD until the wound is 95% re-epithelialised as per the treating clinician. Any adverse events or concerns with patient activity (swimming with dressing, playing in a sandpit) will be documented.
Sponsors
Lady Cilento Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
Inclusion criteria
Children recruited into the study will age between 0 – 16 years that have acquired an acute thermal burn injury that is below 20% of the Total Body Surface Area (TBSA). The child must present to the emergency department or burns outpatient department within 24 hours of sustaining the injury, and have no silver dressing application prior to this admission.
Exclusion criteria
Children outside of the age group will be excluded from the study along with if their mechanism is on e of the following causes; chemical, electrical, inhalation, or friction; children who do not arrive within 24 hours of sustaining their acute burn injury; children who received prior treatment of a silver dressing; are non English speaking; children with cognitive impairments; ventilated or require initial wound care in theatre for debridement or grafting; current involvement with the Department of Communities (child safety); have co-morbidities that would potentially impair would healing (e.g. diabetes) or that may exacerbate itch and pain. Apart from which type of dressing the child is receiving prior to the application of silver, all participants will receive the standard medical care as would those not in the trial.
Outcome results
None listed