Clinical trial NCT01115062: Comparison of Synera Patch Versus LMX-4 Cream Versus Placebo Patch for Pain Reduction During Venipuncture in Children
Official title: Comparison of Lidocaine/Tetracaine Patch (SyneraTM), 4% Liposomal Lidocaine Cream (LMX-4) and Placebo for Pain Reduction During Venipuncture in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Venipuncture
Anesthetics, Local
Keywords: Pain
Children
Local anesthetics
Lead sponsor: CAMC Health System
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Face Pain Scale-Revised (FPS-R)
timeFrame: Before the medication application, after the medication removal and after the venipuncture
Secondary outcomes:
measure: Observed Behavioral Distress Scale (OBDS)
timeFrame: Before, during and after venipuncture
measure: Draize Scale for Adverse Skin Reactions
timeFrame: After removal of the patch or Tegaderm
measure: Venipuncture Difficulty
timeFrame: After venipuncture
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Women and Children Hospital
state: West Virginia
Study officials:
affiliation: Charleston Area Medical Center, Emergency Department
name: James M. Turner, DO
role: PRINCIPAL_INVESTIGATOR
References: