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

Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children

Sponsors

Lead Sponsor: Carol Morreale

Source CAMC Health System
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.

Overall Status Completed
Start Date April 2010
Completion Date June 2011
Primary Completion Date June 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Face Pain Scale-Revised (FPS-R) Before the medication application, after the medication removal and after the venipuncture
Secondary Outcome
Measure Time Frame
Observed Behavioral Distress Scale (OBDS) Before, during and after venipuncture
Draize Scale for Adverse Skin Reactions After removal of the patch or Tegaderm
Venipuncture Difficulty After venipuncture
Enrollment 150
Condition
Intervention

Intervention Type: Drug

Intervention Name: Synera Patch

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

Arm Group Label: Synera Patch

Other Name: Synera

Intervention Type: Drug

Intervention Name: LMX 4 Cream

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

Arm Group Label: LMX-4 Cream

Other Name: LMX-4

Intervention Type: Drug

Intervention Name: Placebo Patch

Description: 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.

Arm Group Label: Placebo Patch

Other Name: 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.

Gender: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
James M. Turner, DO Principal Investigator Charleston Area Medical Center, Emergency Department
Location
Facility: Women and Children Hospital
Location Countries

United States

Verification Date

January 2014

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: CAMC Health System

Investigator Full Name: Carol Morreale

Investigator Title: Clinical Pharmacist Specialist

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Label: Synera Patch

Type: Experimental

Description: Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)

Label: LMX-4 Cream

Type: Experimental

Description: LMX-4 (liposomal lidocaine 4%) cream

Label: Placebo Patch

Type: Placebo Comparator

Description: Placebo Patch

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov