Skip to main content
OpenTrials
Completed

NCT Number: NCT02750137

Ametop - Friend and Foe A Prospective 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tetracaine

Drug

Application of Ametop prior to intravenous cannulation

Other names: Ametop

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2016
Registry last updated
Apr 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.