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

NCT ID: NCT02750137

Last Updated: 2016-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 192 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2015-05-31

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.

Conditions

Adverse Drug Event

Study Design

• Observational Model Type: CASE_ONLY

Interventions

Tetracaine

Application of Ametop prior to intravenous cannulation

Intervention Type: DRUG

Other Intervention Names

Ametop

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Angela Tan Yun June

Senior Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela YJ Tan, MMed

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

References

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. doi: 10.1007/BF03013194.

Reference Type: BACKGROUND

PMID: 10566919 (View on PubMed)

Arrowsmith J, Campbell C. A comparison of local anaesthetics for venepuncture. Arch Dis Child. 2000 Apr;82(4):309-10. doi: 10.1136/adc.82.4.309.

Reference Type: BACKGROUND

PMID: 10735838 (View on PubMed)

Other Identifiers

2015/2158

Identifier Type: -

Identifier Source: org_study_id