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

Phase 2

Completed

• Conditions: Venipuncture; Pain; Anesthetics, Local
• Interventions: Drug: Synera Patch; Drug: LMX 4 Cream; Drug: Placebo Patch

• Registration Number: NCT01115062
• Lead Sponsor: Carol Morreale

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-31
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synera Patch	Synera Patch	Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)
LMX-4 Cream	LMX 4 Cream	LMX-4 (liposomal lidocaine 4%) cream
Placebo Patch	Placebo Patch	Placebo Patch

Primary Outcome Measures

Name	Time	Method
Face Pain Scale-Revised (FPS-R)	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.

Secondary Outcome Measures

Name	Time	Method
Draize Scale for Adverse Skin Reactions	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.
Observed Behavioral Distress Scale (OBDS)	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).
Venipuncture Difficulty	After venipuncture	After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.

Trial Locations

Locations (1)

Women and Children Hospital; 🇺🇸 Charleston, West Virginia, United States