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Completed

NCT Number: NCT01115062

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

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.

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Key information

Conditions

Pain Anesthetics, Local Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Venipuncture

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Women and Children Hospital

Charleston, West Virginia, 25304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synera Patch

Drug

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

Other names: Synera

LMX 4 Cream

Drug

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

Other names: LMX-4

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.

Other names: Placebo

Primary outcomes

  1. Face Pain Scale-Revised (FPS-R)

    Time frame: 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 outcomes

  1. Observed Behavioral Distress Scale (OBDS)

    Time frame: 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).

  2. Draize Scale for Adverse Skin Reactions

    Time frame: 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.

  3. Venipuncture Difficulty

    Time frame: After venipuncture

    After completing the venipuncture the phlebotomist will rate the difficulty of this procedure.

Sponsors and collaborators

Lead sponsor

Carol Morreale

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 4, 2010
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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