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CompletedNCT02750137Updated Apr 25, 2016

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

An observational study in Adverse Drug Event, sponsored by KK Women's and Children's Hospital. Completed. Open to participants aged 1 Month to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-25.

Sponsored by KK Women's and Children's Hospital · Observational

Study type
Observational
Model
Case-only
Enrollment
192
Ages
1 Month to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Adverse Drug Event

Keywords

  • Tetracaine
03

In context

Drug-Related Side Effects and Adverse Reactions

444 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 77 are open to participants now.

This study's enrollment of 192 is below the median of 364 across 162 observational studies indexed under Drug-Related Side Effects and Adverse Reactions.

Browse Drug-Related Side Effects and Adverse Reactions studies →

Lead sponsor

KK Women's and Children's Hospital is the lead sponsor of 137 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any patient who did not have Ametop applied or have an intravenous cannula in situ.
05

Study design

Observational model
Case-only
Enrollment
192 participants (actual)
Patient registry
No

Interventions

  • Application of Ametop prior to intravenous cannulation

    Also known as: Ametop

06

What researchers measure

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

    Time frame: October 2014 to May 2015

Secondary outcomes

  1. Risk factors associated with incidence of skin reactions

    Looking at possible factors associated with skin reactions - race, duration of application, history of atopy

    Time frame: October 2014 to May 2015

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 10566919 ↗
  • 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. PubMed 10735838 ↗

Individual participant data

Plan to share: No — Data will be protected and not shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02750137
Responsible party
Angela Tan Yun June (Senior Resident, KK Women's and Children's Hospital) — Principal investigator
First posted
Apr 25, 2016
Start date
Aug 2014
Primary completion
May 2015
Completion
May 2015
Last update
Apr 25, 2016

Study contacts

Angela YJ Tan, MMed
principal investigator · KK Women's and Children's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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