Topical Analgesia Before Inhalational Anaesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study

Conditions
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Anesthesia, Pediatric ALL

Intervention / Treatment
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* Drug: Topical analgesia (EMLA or AMETOP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All children from 1 month to 18 years of age undergoing elective or urgent inhalational induction of anaesthesia at Nottingham University Hospitals NHS Trust over a six month study period (August 2020 to January 2021) Exclusion Criteria: Children receiving an attempted awake venous cannula insertion Children receiving an a failed intravenous induction of anaesthesia prior to an inhalational induction of anaesthesia Child or family history of malignant hyperthermia Congenital or idiopathic methaemoglobinaemia Glucose-6-phosphate dehydrogenase deficiency (G6PD) Known sensitivity to topical analgesia Use of analgesics within the preceding 24 hours

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed Cohort<br>Children receiving topical analgesia | Drug: Topical analgesia (EMLA or AMETOP)<br>* Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia<br>|
| Control / Unexposed Cohort<br>Children who do not receive topical analgesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient movement | To be used as a surrogate marker of pain. Movement will be defined as reflex hand and/or arm withdrawal and/or the initiation of excitatory movement(s) at the time of needle insertion | Prospective recording by anaesthetist / member of usual care team within 30 minutes of induction of anaesthesia (with completed records stored in RCoA Logbook and Anaesthetic charts) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FTSI (first time successful insertion) of cannula | Rate of FTSI (first time successful insertion) of cannula (with success defined as skin breached only once and the ability to freely instil 5 ml of normal saline intravenously (into the vein)) | Prospective recording by anaesthetist / member of usual care team within 60 minutes of induction of anaesthesia (with completed records stored in RCoA Logbook and Perioperative Care Record) | 
| Overall anaesthetic time | Proxy marker of duration of time to complete cannulation procedure | Prospective recording by member of usual care team within 30 minutes of induction of anaesthesia (with Theatre records retrospectively analysed by research team for 'Anaesthetic Start time to (arrival in) Theatre') | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical analgesia, Inhalational anaesthesia