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

NCT ID: NCT01115062

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Pain; Venipuncture; Anesthetics, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Synera Patch

Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)

Group Type: EXPERIMENTAL

Synera Patch

Intervention Type: DRUG

Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site

LMX-4 Cream

LMX-4 (liposomal lidocaine 4%) cream

Group Type: EXPERIMENTAL

LMX 4 Cream

Intervention Type: DRUG

LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.

Placebo Patch

Placebo Patch

Group Type: PLACEBO_COMPARATOR

Placebo Patch

Intervention Type: DRUG

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.

Interventions

Synera Patch

Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site

Intervention Type: DRUG

LMX 4 Cream

LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Synera; LMX-4; Placebo

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Carol Morreale

OTHER

Sponsor Role: lead

Responsible Party

Carol Morreale

Clinical Pharmacist Specialist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

James M. Turner, DO

Role: PRINCIPAL_INVESTIGATOR

Charleston Area Medical Center, Emergency Department

Locations

Women and Children Hospital

Charleston, West Virginia, United States

Countries

United States

Other Identifiers

09-10-2182

Identifier Type: -

Identifier Source: org_study_id