New Simple Treatment Available to Reduce Pain in Children During Routine Shots and Injections

EMLA(R) Anesthetic Disc Helps Ease Children's Pain from Shots

Source

Astra Pharmaceuticals, L.P.

Forums

Related Articles

The availability of EMLA for pediatric pain associated with needle procedures follows a recent Gallup survey that revealed that children's physical pain during routine visits to the doctor is not being managed or treated adequately.

"The ability of EMLA to dramatically reduce or eliminate pain on injection provides physicians and patients with a significant new tool for effective medical treatment," said Donna Wong, PhD, RN, adjunct Associate Professor in the Department of Pediatrics, University of Oklahoma College of Medicine, Tulsa, OK. "EMLA makes shots and injections less painful for children."

Painless Transdermal Anesthesia

Local anesthetics have long been applied topically to provide anesthesia of the mucous membranes. In these tissues, the penetration barrier is weak and adequate local anesthesia is generally possible. The challenge to providing anesthesia to normal intact skin has, however, been far more difficult to overcome. Various formulations have been tested, but with limited success, in part because to penetrate the skin a high water content is necessary, and in order to provide reliable numbing, a high concentration of the base form of the anesthetic is required.

"EMLA provides a sufficiently high concentration of anesthetic base to produce reliable numbing of the skin," added Dr. Wong. "EMLA's high water content enables the medication to penetrate intact skin, overcoming the challenges that researchers have experienced for years."

EMLA, which can be conveniently applied at home by parents prior to visits to the doctor or in office or clinical settings, is useful in a variety of needle procedures including IV placement, port access, blood and lab draws, lumbar punctures and superficial skin surgery. EMLA Cream is an emulsion composed of lidocaine and prilocaine. The Anesthetic Disc is composed of a laminate backing, an absorbent cellulose disc and an adhesive tape ring that is applied directly to the skin.

EMLA, applied to intact skin under a closed dressing, provides dermal pain relief by the release of lidocaine and prilocaine into the epidermal and dermal layers of the skin and the accumulation of lidocaine and prilocaine in the vicinity of dermal pain receptors and nerve endings. The onset, depth and duration of dermal analgesia provided by EMLA, depends primarily on the duration of application. Satisfactory numbing of the skin is achieved one hour after application, reaching a maximum point at two to three hours after removal from the skin. The period of application should be limited to the minimum required to achieve the desired analgesia.

Clinical Studies Show EMLA to be Safe and Effective

EMLA application in children was studied in seven non-U.S. studies (320 patients) and one U.S. study (11 patients). In placebo controlled studies, application of EMLA for at least one hour with or without presurgical medication prior to needle insertion provided significantly more pain reduction than placebo. EMLA was also compared with placebo in the laser treatment of facial port-wine stains in 72 pediatric patients ages 5-16. EMLA was effective in providing pain relief during laser treatment.

Local dermal effects associated with EMLA application in these studies on intact skin included paleness (pallor or blanching (37%)), redness (erythema (30%)), alteration in temperature sensations (7%), edema (6%), itching (2%) and rash (less than 1%). These local reactions were generally mild and transient, resolving spontaneously within 1 or 2 hours.

EMLA is indicated as a topical anesthetic for use on normal intact skin for local analgesia. EMLA is not recommended for use on mucous membranes, and it is contraindicated for patients with a known history of sensitivity to local anesthetics of the amide type or to any other component of the product. Application of EMLA to larger areas or for longer times than those recommended could result in sufficient absorption of lidocaine and prilocaine resulting in serious adverse effects (see full prescribing information). It should not be used in infants under the age of one month or in those rare patients with congenital or idiopathic methemoglobinemia or in infants under the age of 12 months who are receiving treatment with methemoglobin-inducing agents.

About Astra Pharmaceuticals

Astra Pharmaceuticals, L.P., is the subsidiary of Astra AB of Sweden, an international pharmaceutical company with operations in 45 countries. The company is a leader in the development of pain control, dental, respiratory, gastrointestinal, and cardiovascular products.

CONTACT: Stephanie Pehl, 212-448-4309, or Staci Gouveia, 212-448-4427, both of Ketchum Public Relations, for Astra Pharmacueticals; or Ann Gillespie, of Astra Pharmaceuticals, L.P., 508-836-8489