Phobia PhlebotomyEarly Phase 1NCT01543009
Use of Local Warming in Children Venipuncture
A Early Phase 1 study testing Emla + Local Warming in people with Phobia Phlebotomy, run by University of Florence at 1 site in Italy.
Trial summary
The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously… Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Phobia Phlebotomy
- What is being tested?
- Emla + Local Warming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Oct 2016
- Phase
- Early Phase 1
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 8 and 13 years
- Intravenous drug therapy prescribed by a physician
- no allergy to lidocaine
- no local skin disease
- absence of burns scars
- child and his/her family are native speaker of Italian
- BMI not lower than 10° centile for sex and age according to the CDC standards
Who cannot join
- age of child not included in the age range established for the study
- Intravenous drug therapy not needed
- Presence of an allergy to lidocaine products
- Skin disease
- Presence of burns scars
- The child or his/her family are not native speaker Italian
- BMI lower than 10° centile according to the CDC standards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.
The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.
- Conditions
- Phobia Phlebotomy
- Being tested
- Emla + Local Warming
- Keywords
- child, venipuncture, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emla + Local WarmingOther
In this arm Emla is applied 60 minutes before the procedure and then the site of venepuncture is warmed by an electric heating sand pad at the temperature of 40°C for 5 minutes before performing cannulation
| Study group | Role | What they receive |
|---|---|---|
| Emla + no additional intervention | No intervention | Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming |
| Emla + Local Warming | Experimental | Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) plus warming with a heating pad at 40°C for 5 minutes Receives: Other: Emla + Local Warming |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of success of peripheral venous cannulation at the first attempt
Measured: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Secondary outcomes (3)
pain perceived by the child undergone to the cannulation
The pain level is estimated using a visual analog scale (from 0 to 10) or the Wong "faces'" Scale
Measured: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Difficulty in performing cannulation perceived by Nurse
This outcome is calculated using an "ad hoc" Visual Analog Scale (from 0 to 10)
Measured: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Time needed to obtain cannulation
Time is calculated in seconds
Measured: From positioning tourniquet to completion of cannulation. No follow up is required
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2015
- Study completionOct 2016 (estimated)
Why it stopped: Difficulty in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phobia PhlebotomyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filippo Festini, University of Florence
- Investigators
- Filippo Festini, RN, BA, BSN, MSN, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543009
- Sponsor's protocol ID
- UFI2012WARM
- Status last verified
- Oct 2015
- First submitted
- 27 Feb 2012
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Local Warming in Children to Facilitate Venipuncture. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01543009
- Acronym / sponsor ID
- UFI2012WARM
- Conditions
- Phobia Phlebotomy
- Keywords
- child, venipuncture, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Difficulty in recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 2 Mar 2012 (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.
The aim of this study is to determine if local application of heat increases the probability of insertion of peripheral venous catheter at the first attempt, reduces the time needed to obtain cannulation and maintains the analgesic effect of Emla in children undergoing peripheral venous cannulation and previously treated with local analgesia with Emla.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emla + no additional intervention | No intervention | –Children in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) without warming |
| Emla + Local Warming | Experimental | Other: Emla + Local WarmingChildren in this arm will receive standard preparation of the venipuncture site (local analgesia with Emla) plus warming with a heating pad at 40°C for 5 minutes |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- age between 8 and 13 years
- Intravenous drug therapy prescribed by a physician
- no allergy to lidocaine
- no local skin disease
- absence of burns scars
Key exclusion criteria (7 listed)
- age of child not included in the age range established for the study
- Intravenous drug therapy not needed
- Presence of an allergy to lidocaine products
- Skin disease
- Presence of burns scars
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 |
|---|---|---|
| Emla + Local WarmingIn this arm Emla is applied 60 minutes before the procedure and then the site of venepuncture is warmed by an electric heating sand pad at the temperature of 40°C for 5 minutes before performing cannulation | Other | Emla + Local Warming |
Primary outcome
rate of success of peripheral venous cannulation at the first attempt
Time frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
3 secondary outcomes
pain perceived by the child undergone to the cannulation
Time frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Difficulty in performing cannulation perceived by Nurse
Time frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required
Time needed to obtain cannulation
Time frame: From positioning tourniquet to completion of cannulation. No follow up is required
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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.
Filippo Festini, RN, BA, BSN, MSN principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Emla + Local Warming in people with Phobia Phlebotomy, run by University of Florence at 1 site in Italy.
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 7 inclusion and 7 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: paused, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
rate of success of peripheral venous cannulation at the first attempt (time frame: The outcome is observed and recorded immediatly after the venous cannulation. No follow up is required). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2015.