Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop

Study Overview
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Brief Summary
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Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be higher compared to other studies. This lead to a prospective observational study to look at the incidence and severity of skin reactions following routine clinical application of Ametop.

Detailed Description
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Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. After several critical incidences of adverse reactions that occurred with its application, a departmental audit was carried out to look at the incidence and severity reactions with its application as well as its outcome on intravenous cannulation. The findings of the departmental audit showed that the incidence of adverse reactions seemed to occur more commonly compared to other studies. A prospective observational study was carried out to look at the incidence and severity of skin reactions following routine clinical application of Ametop. This study aims to achieve the following: Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation Assess the success rate of intravenous cannulation Identify the possible risk factors associated with adverse skin reaction.

Official Title
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Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop

Conditions
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Adverse Drug Event

Intervention / Treatment
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* Drug: Tetracaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation. Exclusion Criteria: Any patient who did not have Ametop applied or have an intravenous cannula in situ.

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

| Intervention/Treatment |
| --- |
|Drug: Tetracaine|Application of Ametop prior to intravenous cannulation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of skin reactions with Ametop | looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor | October 2014 to May 2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors associated with incidence of skin reactions | Looking at possible factors associated with skin reactions - race, duration of application, history of atopy | October 2014 to May 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetracaine