Clinical trial NCT02750137: Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop
Official title: Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Event
Keywords: Tetracaine
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-25
Enrollment: 192
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Paediatric patients presenting for surgery in KK Women's and Children's Hospital

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.

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.

Primary outcomes:
measure: Incidence of skin reactions with Ametop
timeFrame: October 2014 to May 2015
Secondary outcomes:
measure: Risk factors associated with incidence of skin reactions
timeFrame: October 2014 to May 2015
Other outcomes:
Locations:
Study officials:
affiliation: KK Women's and Children's Hospital
name: Angela YJ Tan, MMed
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/BF03013194.
citation: 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.