PainPhase 2NCT01115062
Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
A Phase 2 study testing Synera Patch and LMX 4 Cream in people with Pain and Venipuncture, run by Carol Morreale at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Venipuncture, Anesthetics, Local
- What is being tested?
- Synera Patch and LMX 4 Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2011
- Phase
- Phase 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 5 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children requiring venipuncture for medical care
- The ability to demonstrate proper understanding of the Faces Pain Scale-Revised (FPS-R)
- Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain
Who cannot join
- Damaged or inflamed skin at the designated application site
- Known sensitivity to components of Synera or LMX-4 (lidocaine, tetracaine, or local anesthetics of the amide or ester type, PABA derivatives)
- Contraindications to Synera or LMX-4 use (severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
- Use of analgesics during the past 24 hours
- Teenage female participants who are pregnant or lactating
- If in the attending's judgment the patient cannot wait wait 30 minutes for a blood drawn. These conditions include but are not limited to: sepsis, trauma, surgical emergencies, severe dehydration.
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Children Hospital
Charleston, West Virginia, 25304
About this study
Official title: Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children
The purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.
Read the detailed description
This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine 70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and a placebo patch applied for the same length of time in reducing pain due to needle sticks in children. One hundred fifty children and adolescents 5-17 years old admitted to emergency department or presenting to the phlebotomy lab. will be randomly placed in each group. Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the medication is applied, after the medication is removed and after the needle stick. Parents and research observer will fill out the Observed Behavioral Distress (OBD) score. The phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction seen by the investigator after the cream or patch is removed will be noted and compared among the three groups.
Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time Frame for which data will be presented is one (1) year.
- Conditions
- Pain, Venipuncture, Anesthetics, Local
- Being tested
- Synera Patch, LMX 4 Cream, Placebo Patch
- Keywords
- Pain, Children, Local anesthetics
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synera PatchDrug
Also called Synera
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site
LMX 4 CreamDrug
Also called LMX-4
LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.
Placebo PatchDrug
Also called Placebo
A placebo patch with the same properties as the Synera patch but without lidocaine/tetracaine will be administered for 30 minutes to the venipuncture site.
| Study group | Role | What they receive |
|---|---|---|
| Synera Patch | Experimental | Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) Receives: Drug: Synera Patch |
| LMX-4 Cream | Experimental | LMX-4 (liposomal lidocaine 4%) cream Receives: Drug: LMX 4 Cream |
| Placebo Patch | Placebo comparator | Placebo Patch Receives: Drug: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face Pain Scale-Revised (FPS-R)
The child's understanding of the FPS-R will be pretested. Using the scale, the child will rate the level of pain experienced before the medication (patch, cream) application, after the medication removal and after the venipuncture.
Measured: Before the medication application, after the medication removal and after the venipuncture
Secondary outcomes (3)
Observed Behavioral Distress Scale (OBDS)
The parent, and a blinded research observer will complete the Observed Behavioral Distress Scale (OBDS) tool, which evaluates the observed patient distress at placement of the tourniquet (before venipuncture), at the needle insertion (during venipuncture), and at the placement of the adhesive bandage (after venipuncture).
Measured: Before, during and after venipuncture
Draize Scale for Adverse Skin Reactions
The investigator will record the skin reactions after removal of the patch (active or placebo) or the Tegaderm.
Measured: After removal of the patch or Tegaderm
Venipuncture Difficulty
After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.
Measured: After venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Morreale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carol Morreale, CAMC Health System
- Investigators
- James M. Turner, DO, Principal investigator, Charleston Area Medical Center, Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115062
- Sponsor's protocol ID
- 09-10-2182
- Status last verified
- Jan 2014
- First submitted
- 15 Apr 2010
- Last updated
- 4 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children
- ClinicalTrials.gov ID
- NCT01115062
- Acronym / sponsor ID
- 09-10-2182
- Conditions
- Pain, Venipuncture, Anesthetics, Local
- Keywords
- Pain, Children, Local anesthetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Carol MorrealeUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 May 2010 (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 purpose of this study is to compare the effect of Synera patch versus LMX-4 cream and placebo on the level of pain, observed distress, difficulty of venipuncture and skin side effects in children undergoing intravenous blood draw in the emergency setting or the phlebotomy lab.
Detailed description
This study will compare the effectiveness of a patch applied for 30 minutes (Synera-lidocaine 70 mg/tetracaine 70 mg) with the effectiveness of a cream (LMX-4- 4% liposomal lidocaine) and a placebo patch applied for the same length of time in reducing pain due to needle sticks in children. One hundred fifty children and adolescents 5-17 years old admitted to emergency department or presenting to the phlebotomy lab. will be randomly placed in each group. Children will rate their level of pain using the Faces Pain Scale-Revised (FPS-R) before the medication is applied, after the medication is removed and after the needle stick. Parents and research observer will fill out the Observed Behavioral Distress (OBD) score. The phlebotomist will rate how difficult it was to perform the needle sticks. Any skin reaction seen by the investigator after the cream or patch is removed will be noted and compared among the three groups.
Subjects will be monitored from the time of enrollment to 5 minutes post phlebotomy.The Time Frame for which data will be presented is one (1) year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synera Patch | Experimental | Drug: Synera PatchSynera Patch (lidocaine 70 mg/ tetracaine 70 mg) |
| LMX-4 Cream | Experimental | Drug: LMX 4 CreamLMX-4 (liposomal lidocaine 4%) cream |
| Placebo Patch | Placebo comparator | Drug: Placebo PatchPlacebo Patch |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children requiring venipuncture for medical care
- The ability to demonstrate proper understanding of the Faces Pain Scale-Revised (FPS-R)
- Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain
Key exclusion criteria (6 listed)
- Damaged or inflamed skin at the designated application site
- Known sensitivity to components of Synera or LMX-4 (lidocaine, tetracaine, or local anesthetics of the amide or ester type, PABA derivatives)
- Contraindications to Synera or LMX-4 use (severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
- Use of analgesics during the past 24 hours
- Teenage female participants who are pregnant or lactating
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 |
|---|---|---|
| Synera PatchAlso: SyneraSynera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site | Drug | Synera Patch |
| LMX 4 CreamAlso: LMX-4LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site. | Drug | LMX-4 Cream |
| Placebo PatchAlso: PlaceboA placebo patch with the same properties as the Synera patch but without lidocaine/tetracaine will be administered for 30 minutes to the venipuncture site. | Drug | Placebo Patch |
Primary outcome
Face Pain Scale-Revised (FPS-R)
Time frame: Before the medication application, after the medication removal and after the venipuncture
The child's understanding of the FPS-R will be pretested. Using the scale, the child will rate the level of pain experienced before the medication (patch, cream) application, after the medication removal and after the venipuncture.
3 secondary outcomes
Observed Behavioral Distress Scale (OBDS)
Time frame: Before, during and after venipuncture
Draize Scale for Adverse Skin Reactions
Time frame: After removal of the patch or Tegaderm
Venipuncture Difficulty
Time frame: After venipuncture
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 4 Feb 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.
James M. Turner, DO principal investigator
Charleston Area Medical Center, Emergency Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synera Patch and LMX 4 Cream in people with Pain and Venipuncture, run by Carol Morreale 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 3 inclusion and 6 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 4 Feb 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 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. Some participants in this study may receive a placebo. 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 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?
Face Pain Scale-Revised (FPS-R) (time frame: Before the medication application, after the medication removal and after the 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 4 Feb 2014.