Dataset Information

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.

ABSTRACT:

Objective

To compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.

Design

Single-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.

Participants and setting

Paediatric patients (aged ?16) presenting to the Emergency Department at the Queensland Children's Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017-September 2018.

Interventions

Patients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.

Primary and secondary outcomes

Observational pain scores from nursing staff assessed 5?min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.

Results

Seventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: -0.1, 95%?CI -0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95%?CI -8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95%?CI -1.7 to 2.2, p=0.78), heart rate (MD: -3, 95%?CI -11 to 5, p=0.41), temperature (MD: 0.6, 95%?CI -0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95%?CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: -1, 95%?CI -3 to 1, p=0.26) were identified between the two groups.

Conclusions

A clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.

Trial registration number

Australian New Zealand Clinical Trials Registry (ACTRN12617001274369).

SUBMITTER: Holbert MD

PROVIDER: S-EPMC7786810 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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.

Holbert Maleea Denise MD Kimble Roy M RM Chatfield Mark M Griffin Bronwyn R BR

BMJ open 20210105 1

<h4>Objective</h4>To compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.<h4>Design</h4>Single-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.<h4>Participants and setting</h4>Paediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children's Hospital, Brisbane, Australi ...[more]

PMID: 33402404

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Project description: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 ?-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.

Project description:BackgroundPolysaccharide-based hydrogels have been developed for many years to treat burn wounds. Essential oils extracted from aromatic plants generally exhibit superior biological activity, especially antibacterial properties. Studies have shown that antibacterial hydrogels mixed with essential oils have great potential for burn wound healing. This study aimed to develop an antibacterial polysaccharide-based hydrogel with essential oil for burn skin repair.MethodsEucalyptus essential oil (EEO), ginger essential oil (GEO) and cumin essential oil (CEO) were employed for the preparation of effective antibacterial hydrogels physically crosslinked by carboxymethyl chitosan (CMC) and carbomer 940 (CBM). Composite hydrogels were prepared and characterized using antimicrobial activity studies, Fourier-transform infrared spectroscopy, X-ray diffraction, scanning electron microscopy, gas chromatography-mass spectrometery, rheological analysis, viscosity, swelling, water loss rate and water vapor transmission rate studies. In addition, the biocompatibility of hydrogels was evaluated in vivo by cytotoxicity and cell migration assays and the burn healing ability of hydrogels was tested in vivo using burn-induced wounds in mice.ResultsThe different essential oils exhibited different mixing abilities with the hydrogel matrix (CMC and CBM), which caused varying levels of reduction in essential oil hydrogel viscosity, swelling and water vapor transmission. Among the developed hydrogels, the CBM/CMC/EEO hydrogel exhibited optimal antibacterial activities of 46.26 ± 2.22% and 63.05 ± 0.99% against Staphylococcus aureus and Escherichia coli, respectively, along with cell viability (>92.37%) and migration activity. Furthermore, the CBM/CMC/EEO hydrogel accelerated wound healing in mouse burn models by promoting the recovery of dermis and epidermis as observed using a hematoxylin-eosin and Masson's trichrome staining assay. The findings from an enzyme-linked immunosorbent assay demonstrated that the CBM/CMC/EEO hydrogel could repair wounds through interleukin-6 and tumor necrosis factor-α downregulation and transforming growth factor-β, vascular endothelial growth factor (VEGF) and epidermal growth factor upregulation.ConclusionsThis study successfully prepared a porous CBM/CMC/EEO hydrogel with high antibacterial activity, favorable swelling, optimal rheological properties, superior water retention and water vapor transmission performance and a significant effect on skin repair in vitro and in vivo. The results indicate that the CBM/CMC/EEO hydrogel has the potential for use as a promising burn dressing material for skin burn repair.

Dataset Information

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.

Objective

Design

Participants and setting

Interventions

Primary and secondary outcomes

Results

Conclusions

Trial registration number

Publications

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.

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