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

NCT02750137 | Completed

• 1 other identifier: 2015/2158
• Study Type: observational
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Adverse Drug Event

Keywords

Tetracaine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Risk factors associated with incidence of skin reactions

  October 2014 to May 2015

Interventions

Tetracaine DRUG

Application of Ametop prior to intravenous cannulation

Also known as: Ametop

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric patients presenting for surgery in KK Women's and Children's Hospital

You may qualify if:

• All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation.

You may not qualify if:

• Any patient who did not have Ametop applied or have an intravenous cannula in situ.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Related Publications (2)

• 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.

  PMID: 10566919 BACKGROUND

• 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.

  PMID: 10735838 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Tetracaine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Angela YJ Tan, MMed

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 25, 2016
• Study Start: August 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 25, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share