Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
| Status: | Archived |
|---|---|
| Conditions: | Chronic Pain, Hospital |
| Therapuetic Areas: | Musculoskeletal, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | April 2010 |
| End Date: | April 2011 |
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.
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.
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