Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain, Venipuncture, Anesthetics, Local

In brief

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.

Key facts

Study ID

NCT01115062

Run by

Carol Morreale

People needed

150

Starts

2010-04-01

Expected to finish

2011-06-01

Last updated by the study team

2014-02-04

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Women and Children Hospital — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.