The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in Children
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 4 - 12 |
| Updated: | 9/2/2018 |
| Start Date: | June 2007 |
| End Date: | January 2009 |
The Efficacy of the Eutectic Mixture of Local Anesthetics (EMLA) Cream Versus the Synera Patch for Pain Reduction During Venipuncture in Children
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local
Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.
Venipunctures are common and necessary components of pediatric health care. Unfortunately,
many children have "needle phobia" and even a simple procedure, such as a venipuncture, can
cause significant stress and anxiety to the patient and the parents involved. Studies have
shown that needles are the worst part of hospital/healthcare related visits for children.
The Synera patch uses a controlled heating system to transcutaneously deliver a
lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy
of the Synera patch with other topical anesthetics in children. The objective of this study
is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of
EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.
Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to
receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores
using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker
FACES Scale and the NRS, respectively. The primary outcome was the number of subjects
reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain
and the presence of skin reactions.
many children have "needle phobia" and even a simple procedure, such as a venipuncture, can
cause significant stress and anxiety to the patient and the parents involved. Studies have
shown that needles are the worst part of hospital/healthcare related visits for children.
The Synera patch uses a controlled heating system to transcutaneously deliver a
lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy
of the Synera patch with other topical anesthetics in children. The objective of this study
is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of
EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.
Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to
receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores
using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker
FACES Scale and the NRS, respectively. The primary outcome was the number of subjects
reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain
and the presence of skin reactions.
Inclusion Criteria:
- Children in outpatient clinics requiring venipuncture for medical care
- Ages 4-12 years old
- The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking
Scale
- 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 EMLA (lidocaine, tetracaine, or local
anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives)
- Contraindications to SYnera or EMLA use (Severe hepatic disease, history of
drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
- Use of analgesics during the past 24 hours
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