Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
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|ClinicalTrials.gov Identifier: NCT01115062|
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : February 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pain Venipuncture Anesthetics, Local||Drug: Synera Patch Drug: LMX 4 Cream Drug: Placebo Patch||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Synera Patch
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)
Drug: Synera Patch
Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site
Other Name: Synera
Experimental: LMX-4 Cream
LMX-4 (liposomal lidocaine 4%) cream
Drug: LMX 4 Cream
LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.
Other Name: LMX-4
Placebo Comparator: Placebo Patch
Drug: Placebo Patch
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.
Other Name: Placebo
- 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.
- Observed Behavioral Distress Scale (OBDS) [ Time Frame: Before, during and after venipuncture ]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).
- Draize Scale for Adverse Skin Reactions [ Time Frame: After removal of the patch or Tegaderm ]The investigator will record the skin reactions after removal of the patch (active or placebo) or the Tegaderm.
- Venipuncture Difficulty [ Time Frame: After venipuncture ]After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115062
|United States, West Virginia|
|Women and Children Hospital|
|Charleston, West Virginia, United States, 25304|
|Principal Investigator:||James M. Turner, DO||Charleston Area Medical Center, Emergency Department|