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

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ClinicalTrials.gov Identifier: NCT02750137
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
Angela Tan Yun June, 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.

Condition or disease Intervention/treatment
Adverse Drug Event Drug: Tetracaine

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.

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Study Type : Observational
Actual Enrollment : 192 participants
Observational Model: Case-Only
Official Title: Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop
Study Start Date : August 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Tetracaine
    Application of Ametop prior to intravenous cannulation
    Other Name: Ametop


Primary Outcome Measures :
  1. Incidence of skin reactions with Ametop [ Time Frame: October 2014 to May 2015 ]
    looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor


Secondary Outcome Measures :
  1. Risk factors associated with incidence of skin reactions [ Time Frame: October 2014 to May 2015 ]
    Looking at possible factors associated with skin reactions - race, duration of application, history of atopy



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750137


Sponsors and Collaborators
KK Women's and Children's Hospital
Investigators
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Principal Investigator: Angela YJ Tan, MMed KK Women's and Children's Hospital

Publications:
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Responsible Party: Angela Tan Yun June, Senior Resident, KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT02750137     History of Changes
Other Study ID Numbers: 2015/2158
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be protected and not shared.

Keywords provided by Angela Tan Yun June, KK Women's and Children's Hospital:
Tetracaine

Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents