EMLA and Newborns
On March 11, 1999, the Food
and Drug Administration (FDA) approved the use of EMLA (eutectic mixture of
local anesthetics [lidocaine and prilocaine]) for infants born at 37 weeks
gestational age. Since EMLA cream was first approved for use in the United
States in 1993, the pediatric indication was over 1 month of age. The new lower
age limit removes the objection to using EMLA on newborns for common
procedures, such as circumcision, intramuscular injections of vitamin K and
hepatitis B vaccine, and heel lancing for genetic testing or bilirubin levels.
Since infants under 12 months of age are at higher risk for the development of
methemoglobinemia (a rare side effect from prilocaine), practitioners should
apply only the recommended amount of EMLA to the skin. For infants under 5 kg,
the recommended maximum dosage is 1 gm, application area is 10 cm2
(1.25 × 1.25 inches), and application time is 1 hour.
EMLA Anesthetic Disc
In addition to EMLA cream
(available in 5-gm and 30-gm tubes), the EMLA Anesthetic Disc is available. The
Anesthetic Disc is composed of a laminate backing, an absorbent cellulose disc,
and an adhesive tape ring. The disc contains 1 gram of EMLA emulsion, the
active contact surface being approximately 10 cm2. The surface area
of the entire anesthetic disc is approximately 40 cm2.
EMLA and Chest Tube Removal
The peel and stick
disc is excellent for home use to anesthetize small areas (2-inch diameter) on
a relatively flat skin surface. It is not only easy to apply, but is also easy
to remove. Since the anesthetic is in a cellulose disc, the medication does not
leak from under the adhesive covering and is not visible to the child. In a
study of parental application of EMLA cream at home, parents rated the
placement of the occlusive dressing (Tegaderm) as the most difficult part of
the procedure. However, the overall average rating for difficulty of
application was low. Parental application was judged as effective as clinician
application. Additionally, the home use of EMLA decreased the anticipatory
anxiety of children 5 to 12 years for IV placement (Koh and others, 1999). The
availability of the disc should make home use of EMLA even more appealing.
EMLA can effectively and safely minimize or eliminate the pain of numerous types of skin punctures and procedures. Recently, EMLA was shown to be more effective than morphine in reducing the pain associated with chest tube removal. Adult patients (N=100) were randomly assigned to receive either morphine (0.1 mg/kg) IV administered 30 minutes or EMLA cream (5 g) applied three hours before tube removal. The EMLA group had lower pain scores, fewer pain-associated behaviors, and less sedation than the morphine group (Valenzuela and Rosen, 1999).
EMLA and
Acetaminophen
A common concern about using EMLA, especially in
infants under 12 months of age, is its concomitant administration with
acetaminophen (e.g., Tylenol). This concern is reinforced because the package
insert for EMLA lists under "Warnings" that patients taking drugs associated
with drug-induced methemoglobinemia, such as acetaminophen, are at greater risk
for developing methemoglobinemia. However, there have been no reported cases of
this complication occurring in children taking acetaminophen and using EMLA. In
fact, there is no evidence that acetaminophen is a methemoglobin-inducing drug
in humans (Prescott, 1996.) The only reported cases of methemoglobinemia from
acetaminophen have been in cats and dogs (Hjelle & Grauer, 1986).
EMLA Cream and Anesthetic Disc, package insert, Astra Pharmaceuticals, L. P., Wayne, PA, April 1999.
Hjelle JJ, Grauer GF: Acetaminophen-induced toxicosis in dogs and cats, J Am Vet Med Assoc 188(7):742-749, 1986.
Koh JL and others: Efficacy of parental application of eutectic mixture of local anesthetics for intravenous insertion, Pediatrics 103(6):79, 1999.
Prescott LF: Paracetamol (acetaminophen): a critical bibliographic review, Taylor & Francis, Bristol, PA, 1996.
Valenzuela RC and Rosen DA: Topical lidocaine-prilocaine cream (EMLA) for thoracostomy tube removal, Anesth Analg 88:1107-1108, 1999.
Guidelines For Pain Management During Newborn Circumcision
Guidelines For Atraumatic Skin/Vessel Punctures
JCAHO Pain Standards and Hot Line
March 15, 2002