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

NCT01115062 | Completed Phase 2

• 1 other identifier: 09-10-2182
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Venipuncture; Anesthetics, Local

Keywords

Pain; Children; Local anesthetics

Outcome Measures

Primary Outcomes (1)

• Face Pain Scale-Revised (FPS-R)

  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.

  Before the medication application, after the medication removal and after the venipuncture

Secondary Outcomes (3)

• 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

Study Arms (3)

Synera Patch

EXPERIMENTAL

Synera Patch (lidocaine 70 mg/ tetracaine 70 mg)

Drug: Synera Patch

LMX-4 Cream

EXPERIMENTAL

LMX-4 (liposomal lidocaine 4%) cream

Drug: LMX 4 Cream

Placebo Patch

PLACEBO COMPARATOR

Placebo Patch

Drug: Placebo Patch

Interventions

Synera Patch DRUG

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

Also known as: Synera

Synera Patch

LMX 4 Cream DRUG

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

Also known as: LMX-4

LMX-4 Cream

Placebo Patch 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.

Also known as: Placebo

Placebo Patch

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Carol Morreale: lead

Study Sites (1)

Women and Children Hospital

Charleston, West Virginia, 25304, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• James M. Turner, DO

  Charleston Area Medical Center, Emergency Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Pharmacist Specialist

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 4, 2014

Record last verified: 2014-01

Locations

US (1)