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

K

KK Women's and Children's Hospital

Status

Completed

Conditions

Adverse Drug Event

Treatments

Drug: Tetracaine

Study type

Observational

Funder types

Other

Identifiers

NCT02750137
2015/2158

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 patients

Sex

All

Ages

1 month to 18 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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