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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.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАEquivalence TrialНазвание и аннотация: Перевод в очереди
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Holbert Maleea Denise, Kimble Roy M, Chatfield Mark, Griffin Bronwyn R
Аннотация
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).
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).