CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Topical analgesia (EMLA or AMETOP)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04959409
NCT04959409N/ACompleted

Topical Analgesia Before Inhalational Anaesthesia: A Retrospective Observational Study

Nottingham University Hospitals NHS Trust·observational·Posted Jul 13, 2021·Updated Jul 13, 2021

In Brief

An observational study evaluating Topical analgesia (EMLA or AMETOP) for Anesthesia and Pediatric ALL. Completed, enrolled 500 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 13, 2021
Enrollment StartAug 1, 2020
Primary CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.0 years ago

Interventions

Topical analgesia (EMLA or AMETOP)drug

Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia