Rapid, Needle-Free Delivery of Lidocaine for Reducing the Pain of Venipuncture Among Pediatric Subjects

Abstract

ABSTRACT. Objectives. The purpose of this study was to determine the optimal configuration of an investigational, single-use, needle-free, drug system (ALGRX 3268) that delivers powdered lidocaine into the epidermis for the rapid production of local anesthesia among pediatric subjects undergoing venipuncture.Methods. Children 3 to 18 years of age were randomly allocated to receive 1 of 3 treatments, ie, (1) placebo, (2) a system configured to deliver 0.25 mg of lidocaine, or (3) a system configured to deliver 0.5 mg of lidocaine, at the antecubital fossa 2 to 3 minutes before venipuncture. Three age groups were included, ie, 3 to 7 years, 8 to 12 years, and 13 to 18 years. Two sets of pain rating scales were used, the Faces Pain Scale-Revised for the youngest age stratum and a visual analog scale for the oldest age stratum. Children in the middle age stratum used both scales.Results. One-hundred forty-four subjects completed the study. For all ages combined, there was a statistically significant and clinically meaningful reduction in pain scores for subjects who received 0.5 mg of lidocaine, compared with placebo. The reduction in pain after 0.25 mg of lidocaine did not achieve statistical significance.Conclusions. Both active configurations were safe and well tolerated by pediatric subjects undergoing venipuncture at the antecubital fossa. ALGRX 3268 at 0.5 mg, administered 2 to 3 minutes before venipuncture, produced significantly lower pain scores, compared with placebo. [5][6][7][8][9] However, a period of 30 to 90 minutes, depending on the product and the procedure, may be required between application and the onset of effect, limiting the usefulness of these products in busy health care settings and for emergency department applications. [9][10][11] The delivery of lidocaine to the skin through iontophoresis has also been investigated among children undergoing venipuncture or intravenous catheter insertion. 12,13 Iontophoretic lidocaine systems feature a controller and disposable, drug-saturated electrodes and use the application of an electric current to carry ionized lidocaine through the skin. 13 Lidocaine iontophoresis has been shown to be more effective than placebo in reducing the pain of venipuncture and to be comparable to EMLA for intravenous catheter placement. 12,13 However, studies indicate that lidocaine iontophoresis requires up to 15 minutes for onset of effect. 14 This study was undertaken to evaluate an investigational, needle-free, single-use, prefilled, disposable system (ALGRX 3268; AlgoRx Pharmaceuticals Inc, Secaucus, NJ) capable of delivering fine, dry, powdered lidocaine into the epidermis for the rapid production (within 1-3 minutes) of local anesthesia before venipuncture. The system is placed against the skin at the site of venipuncture and is triggered simply by pressing of the actuator button (Fig 1). Pressurized, medical-grade, helium gas within the system accelerates lidocaine particles to velocities sufficient to penetrate the outer skin layers and produce local anesthesia. ...

Pharmacologic Approaches for Reducing Venous Access Pain in Children

“…94 The significant analgesic effects of the LHM powder intradermal injection system have been demonstrated in pediatric populations undergoing venipuncture (Table 5). [95][96][97] In 1 randomized double-blind study, 307 children aged 3 to 18 years were randomly assigned to receive a predecessor system similar to the currently approved device or matching sham placebo at the back of the hand 2 to 3 minutes before venipuncture. 97 Subjects who received the active system exhibited mean pain reductions (effect sizes) of 33% to 46% relative to sham placebo.…”

A Randomized, Controlled Trial of the Reciprocating Procedure Device for Local Anesthesia

“…Most clinicians simply accept that administration of lidocaine will cause pain, and do not alter their individual anesthesia administration technique. However, the problem of pain during administration of local anesthesia is so considerable that transdermal approaches, needleless administration, and computer-assisted injection techniques are areas of intense research and clinical study (7,(12)(13)(14)(15)(16)(17)(18)(19). A less painful drug delivery device such as the RPD is another logical approach.…”

“…Considerable attention has been directed to the proper syringe and needle technique during local anesthesia (8 -11). Buffering the local anesthetic agent as well as the development of alternative delivery methods to lessen the pain associated with local anesthesia have been reported (12)(13)(14)(15)(16)(17)(18)(19). Although obviously contributing to the pain experience, poor control of the needle and syringe by the operator during local anesthesia has not been well studied.…”

Effective use of transdermal drug delivery in children

“…Overall, the children found the needle-free device easier to use and more comfortable than their insulin needle injection, and 74% preferred it over needles. Another investigational, single-use, disposable powder-jet injector (ALGRX 3268), which delivered powdered lidocaine (0.35 µm particle size) was investigated in 145 (3-18 y) children for its ability to reduce pain before venipuncture [191]. A placebo (empty drug cassette) and injectors delivering 0.25 and 0.5 mg of lidocaine were compared; all three contained helium gas pressurized at 20 bar.…”