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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02750137

Enrollment

192

Registered

2016-04-25

Start date

2014-08-31

Completion date

2015-05-31

Last updated

2016-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Drug Event

Keywords

Tetracaine

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.

Interventions

DRUGTetracaine

Application of Ametop prior to intravenous cannulation

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026