Topical Analgesia Before Inhalational Anaesthesia

July 1, 2021 updated by: Nottingham University Hospitals NHS Trust

Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient movement
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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')
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')

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: M Billingham, MB.ChB, Nottingham University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2021

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20AN008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual participant data will be disclosed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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