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Reducing distress for children during invasive procedures: randomized clinical trial of effectiveness of the

Stephen C Brown1, Geoff Hart, David P Chastain

  • 1Department of Anesthesia & Pain Medicine, The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada.

Paediatric Anaesthesia
|July 24, 2009
PubMed

Insights

The PediSedate system, combining nitrous oxide with interactive video, significantly reduced distress and pain in young children during medical procedures compared to standard care. This innovative approach improved cooperation and procedural outcomes for pediatric patients.

Area of Science:

  • Pediatric Emergency Medicine
  • Anesthesiology
  • Child Psychology

Background:

  • Procedural pain and anxiety are significant challenges in pediatric care, particularly when deep sedation is not advisable.
  • The PediSedate system was developed to provide procedural pain control using nitrous oxide and oxygen via a nosepiece, integrated with an interactive video for distraction.
  • This system aims to enable children to manage anxiety through attention and distraction during drug delivery.

Purpose of the Study:

  • To evaluate the effectiveness of the PediSedate system in reducing behavioral distress in children during emergency department procedures.
  • To compare the PediSedate system against standard care in a randomized clinical trial.
  • To assess secondary outcomes including children's acceptance, cooperation, and reported pain levels.

Main Methods:

  • A randomized clinical trial involving 36 children aged 3-9 years undergoing anxiety-provoking, low-pain procedures (e.g., sutures, IV insertion, lumbar punctures).
  • Participants were randomized to receive either standard care or the PediSedate system.
  • The primary outcome measure was children's distress, assessed using an observational scale of behavioral distress before and during the procedure.

Main Results:

  • Children using the PediSedate system exhibited significantly lower distress levels during procedures (mean = 1.8) compared to those receiving standard care (mean = 9.3; P < 0.0001).
  • The PediSedate group demonstrated significantly improved cooperation (P < 0.0001) and reported less pain (P < 0.001) than the standard care group.

Conclusions:

  • The PediSedate system, delivering nitrous oxide sedation combined with an interactive video component, is effective in minimizing pain and distress during invasive pediatric procedures.
  • This approach offers a viable alternative to traditional methods, enhancing patient comfort and cooperation.
  • Further research is recommended to identify dominant contributing factors and compare the failure rates of this delivery system against others.
Abstract

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