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

April 22, 2016 updated by: Angela Tan Yun June, KK Women's and Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

192

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Paediatric patients presenting for surgery in KK Women's and Children's Hospital

Description

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 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Angela YJ Tan, MMed, KK Women's and Children's Hospital

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

August 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 17, 2016

First Submitted That Met QC Criteria

April 22, 2016

First Posted (Estimate)

April 25, 2016

Study Record Updates

Last Update Posted (Estimate)

April 25, 2016

Last Update Submitted That Met QC Criteria

April 22, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015/2158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be protected and not shared.

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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