NCT02750137

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
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Adverse Drug Event

Interventions

Type	Name	Description
DRUG	Tetracaine	Application of Ametop prior to intravenous cannulation

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2016-04-25
• Last updated: 2016-04-25