Adverse Drug EventNCT02750137
Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop
An observational study of Adverse Drug Event, run by KK Women's and Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Drug Event
- What is being tested?
- Tetracaine
- Type of treatment
- Injection or infusion
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Paediatric patients presenting for surgery in KK Women's and Children's Hospital
Who may be able to join
- All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation.
Who cannot join
- Any patient who did not have Ametop applied or have an intravenous cannula in situ.
About this study
Official title: Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop
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:
- Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation
- Assess the success rate of intravenous cannulation
- Identify the possible risk factors associated with adverse skin reaction.
- Conditions
- Adverse Drug Event
- Being tested
- Tetracaine
- Keywords
- Tetracaine
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracaineDrug
Also called Ametop
Application of Ametop prior to intravenous cannulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of skin reactions with Ametop
looking at the incidence of skin reactions with Ametop - normal, simple erythema, raised erythema, itch, pallor
Measured: 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
Measured: October 2014 to May 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Drug EventStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Angela Tan Yun June, KK Women's and Children's Hospital
- Investigators
- Angela YJ Tan, MMed, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750137
- Sponsor's protocol ID
- 2015/2158
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be protected and not shared.
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 10566919Arrowsmith 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ametop - Friend or Foe A Prospective Observational Study of the Incidence of Adverse Reactions With Ametop
- ClinicalTrials.gov ID
- NCT02750137
- Acronym / sponsor ID
- 2015/2158
- Conditions
- Adverse Drug Event
- Keywords
- Tetracaine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- Aug 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation
- Assess the success rate of intravenous cannulation
- Identify the possible risk factors associated with adverse skin reaction.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients presenting for surgery in KK Women's and Children's Hospital
Key inclusion criteria (1 listed)
- All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation.
Key exclusion criteria (1 listed)
- Any patient who did not have Ametop applied or have an intravenous cannula in situ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetracaineAlso: AmetopApplication of Ametop prior to intravenous cannulation | Drug | – |
Primary outcome
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
1 secondary outcome
Risk factors associated with incidence of skin reactions
Time frame: October 2014 to May 2015
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2016.
- Background: PubMed 10566919Browne 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.
- Background: PubMed 10735838Arrowsmith 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.
- Individual participant dataSharing planned: No. Data will be protected and not shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela YJ Tan, MMed principal investigator
KK Women's and Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Event, run by KK Women's and Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of skin reactions with Ametop (time frame: October 2014 to May 2015). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750137, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2016.