Ignite Creation Date:
2024-05-06 @ 4:19 PM
Last Modification Date:
2024-10-26 @ 2:08 PM
Study NCT ID:
NCT04959409
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2021-06-07
Brief Title:
Topical Analgesia Before Inhalational Anaesthesia
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Topical Analgesia Before Inhalational Anaesthesia A Retrospective Observational Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 associations andor potential benefits 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
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 associations andor potential benefits 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None