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

Adverse Drug Event Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750137
• Other study ID #: 2015/2158
• Status: Completed
• Phase: N/A
• First received: April 17, 2016
• Last updated: April 22, 2016
• Start date: August 2014
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

Drug:
• Tetracaine
Application of Ametop prior to intravenous cannulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

References & Publications (2)

Arrowsmith J, Campbell C. A comparison of local anaesthetics for venepuncture. Arch Dis Child. 2000 Apr;82(4):309-10. — View Citation

Browne J, Awad I, Plant R, McAdoo J, Shorten G. Topical amethocaine (Ametop) is superior to EMLA for intravenous cannulation. Eutectic mixture of local anesthetics. Can J Anaesth. 1999 Nov;46(11):1014-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of skin reactions with Ametop	looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor	October 2014 to May 2015	No
Secondary	Risk factors associated with incidence of skin reactions	Looking at possible factors associated with skin reactions - race, duration of application, history of atopy	October 2014 to May 2015	No