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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Carol Morreale
• Treatments: Lidocaine; Tetracaine

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.