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Randomized Controlled Trial
. 2021 Jan 5;11(1):e039981.
doi: 10.1136/bmjopen-2020-039981.

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

Maleea Denise Holbert  1   2   3 , Roy M Kimble  4   2   3   5 , Mark Chatfield  3 , Bronwyn R Griffin  4   2   5   6
Affiliations
Randomized Controlled Trial

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

Maleea Denise Holbert et al. BMJ Open. .

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).

Keywords: accident & emergency medicine; paediatrics; pain management; wound management.

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Conflict of interest statement

Competing interests: All authors who contributed to this original research manuscript declare no conflicts of interests. All authors declare no financial or other interests in the product (Burnaid) or distributor of the product (Mundipharma). All authors declare no past or existing relationships with the manufacturer or distributor of the product. Moreover, all authors declare no additional associations with the product manufacturer or distributor including consultancies, stock ownership, or other equity interests or patent-licensing arrangements.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials flow diagram. TBSA, total body surface area.
Figure 2
Figure 2
Pain assessment timepoints during acute and follow-up care.
See this image and copyright information in PMC

References

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