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 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 wo...
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| Format: | Article |
| Language: | English |
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BMC
2019-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-3057-x |
| _version_ | 1811339905552351232 |
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| author | Maleea D. Holbert Bronwyn R. Griffin Steven M. McPhail Robert S. Ware Kelly Foster Demi C. Bertoni Roy M. Kimble |
| author_facet | Maleea D. Holbert Bronwyn R. Griffin Steven M. McPhail Robert S. Ware Kelly Foster Demi C. Bertoni Roy M. Kimble |
| author_sort | Maleea D. Holbert |
| collection | DOAJ |
| description | 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 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. 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. |
| first_indexed | 2024-04-13T18:33:21Z |
| format | Article |
| id | doaj.art-915e3f26cb3647008f21cbca047fbe06 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-13T18:33:21Z |
| publishDate | 2019-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-915e3f26cb3647008f21cbca047fbe062022-12-22T02:34:58ZengBMCTrials1745-62152019-01-0120111310.1186/s13063-018-3057-xEffectiveness 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 trialMaleea D. Holbert0Bronwyn R. Griffin1Steven M. McPhail2Robert S. Ware3Kelly Foster4Demi C. Bertoni5Roy M. Kimble6Centre for Children’s Burns and Trauma Research, The University of QueenslandCentre for Children’s Burns and Trauma Research, The University of QueenslandCentre for Functioning and Health Research, Metro South HealthMenzies Health Institute Queensland, Griffith UniversityPaediatric Emergency Research Unit, Children’s Health QueenslandPegg Leditschke Paediatric Burns Centre, Lady Cilento Children’s HospitalCentre for Children’s Burns and Trauma Research, The University of QueenslandAbstract 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 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. 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.http://link.springer.com/article/10.1186/s13063-018-3057-xPaediatricBurnsFirst aidHydrogelBurnaid®Re-epithelialisation |
| spellingShingle | Maleea D. Holbert Bronwyn R. Griffin Steven M. McPhail Robert S. Ware Kelly Foster Demi C. Bertoni Roy M. Kimble 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 Paediatric Burns First aid Hydrogel Burnaid® Re-epithelialisation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Paediatric Burns First aid Hydrogel Burnaid® Re-epithelialisation |
| url | http://link.springer.com/article/10.1186/s13063-018-3057-x |
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