PainPhase 4NCT00126932
Reduction of Topical Anesthetic Onset Time Using Ultrasound
A Phase 4 study testing SonoPrep in people with Pain, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Pain
- What is being tested?
- SonoPrep
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Dec 2004
- Phase
- Phase 4
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 3-7, requiring venipuncture
Who cannot join
- Emergent procedure
- Allergy to lidocaine or sodium lauryl sulfate
Trial locations and contacts
1 site in 1 country.
United States1 site
CT Children's Medical Center
Hartford, Connecticut, 06106
About this study
Official title: Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children
Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.
- Conditions
- Pain
- Being tested
- SonoPrep
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoPrepDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
pain associated with venipuncture
Secondary outcomes (3)
safety
skin effects
tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startOct 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- William T. Zempsky, MD, Principal investigator, CT Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126932
- Sponsor's protocol ID
- 05-003
- Status last verified
- Dec 2007
- First submitted
- 3 Aug 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Topical Anesthetic Onset Time Using Ultrasound: A Randomized Controlled Trial Prior to Venipuncture in Young Children
- ClinicalTrials.gov ID
- NCT00126932
- Acronym / sponsor ID
- 05-003
- Conditions
- Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Dec 2004
- First posted
- 5 Aug 2005 (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.
Children ages 3-7 who are undergoing blood drawing receive either standard care, topical medicine for numbing (LMX4), or the study intervention which utilizes ultrasound to speed the onset of LMX4 from 30 minutes to 5 minutes. The child's pain with the blood drawing procedure is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Ages 3-7, requiring venipuncture
Key exclusion criteria (2 listed)
- Emergent procedure
- Allergy to lidocaine or sodium lauryl sulfate
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 |
|---|---|---|
| SonoPrep | Device | – |
Primary outcome
pain associated with venipuncture
3 secondary outcomes
safety
skin effects
tolerability
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 27 Dec 2007.
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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.
William T. Zempsky, MD principal investigator
CT Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SonoPrep in people with Pain, run by Connecticut Children's Medical Center at 1 site in United States.
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 2 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 27 Dec 2007. 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 United States. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain associated with venipuncture. 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 27 Dec 2007.