Topical Analgesia Before Inhalational Anaesthesia
Condition: Anesthesia; Pediatric ALL
Study type: Observational

Summary: 
      Peripheral venous cannulation (insertion of a drip line into a vein) is a fundamental
      component of anaesthesia for both children and adults alike. Discomfort caused by needle
      insertion is a common worry for children but one simple intervention that may be delivered
      prior to a needle insertion procedure, is the application of topical analgesia (numbing skin
      cream). Several creams are now available and have been found to be effective in several
      trials of awake children. Yet the value of these creams for children receiving an
      inhalational induction of anaesthesia (gas to go off to sleep before needle insertion)
      remains uncertain.

      The aims of this study are to determine whether cream application prior to receiving gas to
      go off to sleep has any beneficial effects (outcomes) for children, including reduction of
      movement, improved needle success rates and reduced time required for needle insertion
      procedures. How frequently skin effects after application of the creams occur (swelling,
      redness, itchiness) will also be assessed.

      This study will be performed as a retrospective observational study (a study which looks back
      in time, identifies groups of exposed (cream applied) or non-exposed (no cream applied)
      children and follows them over a period of time to see how their exposures affect their
      outcomes). Using a total population (purposive) sampling technique, 500 children from 1 month
      to 18 years of age undergoing elective (planned) or urgent (emergency) inhalational induction
      of anaesthesia (gas to go off to sleep) at Nottingham University Hospitals NHS Trust over a
      six month study period (August 2020 to January 2021) will be incorporated into a completely
      anonymised research dataset and analysed to determine whether topical analgesia (skin numbing
      cream) application prior to inhalational induction (gas to go off to sleep) may offer any
      beneficial effects for paediatric patients.
    

Detailed description: 
      This study will be performed as a retrospective cohort observational study (a study which
      looks back in time, identifies cohorts (groups) of 'exposed' (those who received topical
      analgesia (skin numbing cream)) and 'non-exposed' (those who did not receive topical
      analgesia (skin numbing cream)) children and follows them over a period of time to see how
      their exposures affect their outcomes).

      Since no studies have been conducted to date, to determine the value of topical analgesia
      (skin numbing cream) for children receiving an inhalational induction of anaesthesia (gas to
      go off to sleep), this has been designed as a non-randomised preparatory study. Being
      non-experimental in nature, this study will attempt to evaluate preliminary null hypotheses
      of association. Where association(s) and/or potential benefit(s) are observed to a
      statistically significant level, the value and feasibility of a future experimental study, in
      the form of a prospective randomised controlled trial, will be evaluated.

      Through acting as a first step in exploring a novel intervention, this approach is felt to
      offer a safe and cost-effective indication of the value a future large-scale experimental
      trial, which in an uninvestigated field and with only a suggestible potential for benefit,
      would face numerous approval challenges.
    

Intervention name(s): Topical analgesia (EMLA or AMETOP)
Intervention type(s): Drug
Intervention description(s): Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia
Intervention MeSH terms: Tetracaine
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Of the children who may become study participants (identified as being eligible and not
        meeting the study exclusion criteria) a random sampling technique will be utilised to
        recruit 500 children
      
Keywords: Topical analgesia; Inhalational anaesthesia