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

Sponsor

KK Women's and Children's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02750137

Collaborator

(none)

192

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Drug Event	Drug: Tetracaine

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:

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.

Study Design

Study Type:

Observational

Actual Enrollment :

192 participants

Observational Model:

Case-Only

Official Title:

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

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

KK Women's and Children's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Angela Tan Yun June, Senior Resident, KK Women's and Children's Hospital

ClinicalTrials.gov Identifier:

NCT02750137

Other Study ID Numbers:

2015/2158

First Posted:

Apr 25, 2016

Last Update Posted:

Apr 25, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Angela Tan Yun June, Senior Resident, KK Women's and Children's Hospital

Tetracaine

Additional relevant MeSH terms:

Tetracaine

Study Results

No Results Posted as of Apr 25, 2016