Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children
Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
Sponsors
Source
CAMC Health System
Oversight Info
Has Dmc
No
Brief 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.
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.
Overall Status
Completed
Start Date
2010-04-01
Completion Date
2011-06-01
Primary Completion Date
2011-06-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Face Pain Scale-Revised (FPS-R) |
Before the medication application, after the medication removal and after the venipuncture |
Secondary Outcome
Measure |
Time Frame |
|
Observed Behavioral Distress Scale (OBDS) |
Before, during and after venipuncture |
|
Draize Scale for Adverse Skin Reactions |
After removal of the patch or Tegaderm |
|
Venipuncture Difficulty |
After venipuncture |
Enrollment
150
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site
Arm Group Label
Synera Patch
Other Name
Synera
Intervention Type
Drug
Intervention Name
Description
LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.
Arm Group Label
LMX-4 Cream
Other Name
LMX-4
Intervention Type
Drug
Intervention Name
Description
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.
Arm Group Label
Placebo Patch
Other Name
Placebo
Eligibility
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Gender
All
Minimum Age
5 Years
Maximum Age
17 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
James M. Turner, DO |
Principal Investigator |
Charleston Area Medical Center, Emergency Department |
Location
Facility |
|
Women and Children Hospital Charleston West Virginia 25304 United States |
Location Countries
Country
United States
Verification Date
2014-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
CAMC Health System
Investigator Full Name
Carol Morreale
Investigator Title
Clinical Pharmacist Specialist
Keywords
Has Expanded Access
No
Number Of Arms
3
Intervention Browse
Mesh Term
Lidocaine
Tetracaine
Arm Group
Arm Group Label
Synera Patch
Arm Group Type
Experimental
Description
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)
Arm Group Label
LMX-4 Cream
Arm Group Type
Experimental
Description
LMX-4 (liposomal lidocaine 4%) cream
Arm Group Label
Placebo Patch
Arm Group Type
Placebo Comparator
Description
Placebo Patch
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
April 15, 2010
Study First Submitted Qc
May 3, 2010
Study First Posted
May 4, 2010
Last Update Submitted
January 31, 2014
Last Update Submitted Qc
January 31, 2014
Last Update Posted
February 4, 2014
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.