PainPhase 1/2NCT00562211
Efficacy of a New Topical Anesthetic
A Phase 1/2 study testing LidoDyn and EMLA creme in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn). The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème). Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- LidoDyn and EMLA creme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to Apr 2008
- Phase
- Phase 1/2
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously healthy children of whom venipuncture is needed to be performed.
Who cannot join
- History of allergic reaction to any local anesthetic.
- History of chronic disease
- Patient's condition requires urgent treatment (e.g. severe dehydration, shock)
- Active local skin infection or skin pathologic condition at the antecubital fossa
- Tattoo, surgical scar or skin condition that might interfere with skin sight assessment.
- Patient undergone venipuncture at the antecubital fossa within the pror two weeks.
- Uncooperative or exceptionally anxious patient.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus
Haifa
About this study
Official title: A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn).
The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).
- Conditions
- Pain
- Being tested
- LidoDyn, EMLA creme
- Keywords
- children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidoDynDrug
Application of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
EMLA cremeDrug
Application of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: LidoDyn |
| 2 | Active comparator | Not described Receives: Drug: EMLA creme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report assessment of pain (using the Visual Analog Scale)
Measured: 60 Min+ 5-10 Min
Secondary outcomes (1)
Medical staff observational assessment of pain (in a scale of 0 to 10)
Measured: 60 Min + 5-10 Min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionApr 2008
- Study completionApr 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, i_shavit, Rambam Health Care Campus
- Investigators
- Itai Shavit, M.D., Principal investigator, Rambam Health Care CampusHadas Knaani-Levinz, M.D., Principal investigator, Rambam Health Care CampusAmir Hadash, M.D., Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562211
- Sponsor's protocol ID
- 2465CTIL
- Other IDs
- 2465
- Status last verified
- Nov 2007
- First submitted
- 20 Nov 2007
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
- ClinicalTrials.gov ID
- NCT00562211
- Acronym / sponsor ID
- 2465CTIL
- Conditions
- Pain
- Keywords
- children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 21 Nov 2007 (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.
A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn).
The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: LidoDyn |
| 2 | Active comparator | Drug: EMLA creme |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Previously healthy children of whom venipuncture is needed to be performed.
Key exclusion criteria (7 listed)
- History of allergic reaction to any local anesthetic.
- History of chronic disease
- Patient's condition requires urgent treatment (e.g. severe dehydration, shock)
- Active local skin infection or skin pathologic condition at the antecubital fossa
- Tattoo, surgical scar or skin condition that might interfere with skin sight assessment.
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 |
|---|---|---|
| LidoDynApplication of 2 gram of LidoDyn to the skin surface the patient's antecubital fossa 60 min prior to venipuncture | Drug | 1 |
| EMLA cremeApplication of 2 gram of EMLA creme to the skin surface the patient's antecubital fossa 60 min prior to venipuncture | Drug | 2 |
Primary outcome
Self report assessment of pain (using the Visual Analog Scale)
Time frame: 60 Min+ 5-10 Min
1 secondary outcome
Medical staff observational assessment of pain (in a scale of 0 to 10)
Time frame: 60 Min + 5-10 Min
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 6 May 2014.
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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.
Itai Shavit, M.D. principal investigator
Rambam Health Care Campus
Hadas Knaani-Levinz, M.D. principal investigator
Rambam Health Care Campus
Amir Hadash, M.D. principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LidoDyn and EMLA creme in people with Pain, run by Rambam Health Care Campus at 1 site in Israel.
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 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: finished, as of the sponsor's last update on 6 May 2014. 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 Israel. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Self report assessment of pain (using the Visual Analog Scale) (time frame: 60 Min+ 5-10 Min). 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 6 May 2014.