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

Completed

• Conditions: Adverse Drug Event

• Registration Number: NCT02750137
• Lead Sponsor: KK Women's and Children's Hospital

Brief Summary

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

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:

1. Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation

2. Assess the success rate of intravenous cannulation

3. Identify the possible risk factors associated with adverse skin reaction.

Study Timeline

• Study Start: 2014-08
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-04
• Study First Submitted: 2016-04-17
• Study First Submitted QC: 2016-04-22
• Last Update Submitted: 2016-04-22
• Study First Posted: 2016-04-25
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of skin reactions with Ametop	October 2014 to May 2015	looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor

Secondary Outcome Measures

Name	Time	Method
Risk factors associated with incidence of skin reactions	October 2014 to May 2015	Looking at possible factors associated with skin reactions - race, duration of application, history of atopy