Lidocaine iontophoresis for topical anesthesia before intravenous line placement in children

doi:10.1016/S0022-3476(98)70413-5

The Journal of Pediatrics

Volume 132, Issue 6, June 1998, Pages 1061-1063

Presented at the Annual Meeting of the American Academy of Pediatrics, Section of Emergency Medicine, Boston, Massachusetts, October 26-30, 1996.

https://doi.org/10.1016/S0022-3476(98)70413-5 Get rights and content

Abstract

In a double-blind randomized trial including 42 children aged 7 to 18 years, less pain occurred with intravenous placement after iontophoresis of 2% lidocaine with epinephrine, as reported by patients (p = 0.005), parents (p = 0.001), intravenous personnel (p = 0.009), and investigators (p = 0.0002) compared with placebo therapy. Lidocaine iontophoresis provides rapid and effective topical anesthesia for intravenous access in children. (J Pediatr 1998;132:1061-3.)

Section snippets

Study Design

Patients in an emergency department who were between 7 and 18 years old and required intravenous access were randomized to lidocaine (2%, with 1:100,000 epinephrine, N = 22) or placebo (normal saline solution, with 1:100,000 epinephrine, N = 20). Patients who required emergent placement of intravenous catheters or who had unstable vital signs, clinical evidence of dehydration, lidocaine allergy, decreased mental status, or a pacemaker were excluded. Children with mental retardation and those

RESULTS

There were no significant differences in the demographic variables between the lidocaine and placebo groups. Iontophoresis (30 mAmin) required 10.8 ± 3.6 minutes in the lidocaine and 10.7 ± 3.5 minutes in the placebo group (p = NS).

Less pain occurred during intravenous placement in the lidocaine group than in the placebo group, measured by 100 mm visual analog scales (p = 0.005, Table) and by the ordinal pain scale (p = 0.002).

Table. Visual analog scale scores for pain at time of intravenous

DISCUSSION

From a double-blind randomized trial we report that the topical anesthesia after lidocaine iontophoresis effectively reduces the pain from intravenous catheter placement in children, thus confirming the results of a similar study in 44 adult patients.⁵ The success rate for intravenous access in our study was approximately 80% and was similar to the success rates reported for intravenous access in patients in a pediatric emergency department.⁸

Tingling, warmth, itching, and erythema beneath the

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The earliest paediatric application was the iontophoretic delivery of lidocaine to provide local anaesthesia prior to venous sampling and minor dermatological interventions. Implementation first involved the use of a power supply (Iomed® Phoresor II Auto) and disposable electrodes, which could be either filled prior to use by the practitioner [159] or prefilled (NumbyStuff®) [160] with a solution containing 2% lidocaine and 1:100,000 epinephrine. The second active aimed to induce local vasoconstriction and reduce lidocaine clearance into the systemic circulation.
Transdermal administration offers a non-invasive and convenient method for paediatric drug delivery. The competent skin barrier function in term infants and older children limits both water loss and the percutaneous entry of chemicals including drugs; but the smaller doses required by children eases the attainment of therapeutic concentrations. Transdermal patches used in paediatrics include fentanyl, buprenorphine, clonidine, scopolamine, methylphenidate, oestrogens, nicotine and tulobuterol. Some patches have paediatric labelling supported by clinical trials whereas others are used unlicensed. Innovative drug delivery methods, such as microneedles and sonophoresis are being tested for their safety and efficacy; needleless injectors are primarily used to administer growth hormone; and two iontophoretic devices were approved for paediatrics. In contrast, the immature and rapidly evolving skin barrier function in premature neonates represents a significant formulation challenge. Unfortunately, this population group suffers from an absence of approved transdermal formulations, a shortcoming exacerbated by the significant risk of excessive drug exposure via the incompletely formed skin barrier.
Next generation intra- and transdermal therapeutic systems: Using non- and minimally-invasive technologies to increase drug delivery into and across the skin
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The number of drug molecules approved by the regulatory authorities for transdermal administration is relatively modest – less than two dozen. Many other therapies might benefit from the advantages offered by the transdermal route. That they have not already done so is due to the exceptional efficacy of the stratum corneum as a diffusional barrier and its remarkable ability to restrict molecular transport. As a result only extremely potent therapeutics possessing the necessary physicochemical properties can be delivered by passive diffusion across intact skin at pharmacologically relevent rates. This has led to the development of several delivery technologies that might be used to expand the range of medicinal agents that can be administered transdermally with the requisite delivery kinetics. There are essentially two approaches: (i) provide an improved driving force to increase the rate of transport (i.e., act on the molecule) or (ii) modify the properties of the microenvironment through which diffusion must occur (i.e., act on the stratum corneum). The challenge for the latter approach is to compromise the barrier in a reversible and relatively painless manner that minimises irritation, is practical for chronic conditions and has minimal risk of infection. Here, we review some of the physical methods that have been used to either transiently perturb the skin barrier or to provide additional driving forces to facilitate molecular transport with a particular focus on technologies that have either led to marketed products or have at least reached the clinical development stage.
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It is a common practice for medical practitioners to use subcutaneous infiltration of lidocaine to alleviate the pain of intravenous cannulation or line insertion. Although previous studies have assessed several factors affecting the pain associated with local anesthetic infiltration, there is a paucity of data on the effects of needle bevel position. In this prospective, randomized, controlled trial, we compared the effect of two different needle bevel positions (bevel up versus bevel down) and the pain associated with the subcutaneous injection of 1% lidocaine in 50 adult volunteers. Significantly higher pain scores were observed when the needle was placed bevel down compared with bevel up (P = .02). No significant differences in pain scores were noted between the groups for age and gender.
Warm Lidocaine/Tetracaine Patch Versus Placebo Before Pediatric Intravenous Cannulation: A Randomized Controlled Trial
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Even liposomal formulations of lidocaine and tetracaine require a minimum of 30 minutes before onset.7 Methods to enhance transdermal absorption and shorten the time to onset have included iontophoresis, sonophoresis, needless injection, laser ablation of the stratum corneum, and tape stripping.8-12 However, each of these methods also has specific limitations, especially in the ED setting.
We compare the pain of intravenous (IV) cannulation in pediatric emergency department (ED) patients after applying a topical lidocaine/tetracaine patch versus placebo. We hypothesized that application of the active patch would reduce the pain of IV cannulation by at least 15 mm.
We conducted a randomized, double-blind, placebo-controlled trial in a suburban academic ED. Patients aged 3 to 17 years who required nonemergency IV cannulation were eligible for enrollment. At triage, a nurse placed a commercially available topical lidocaine/tetracaine patch or an identical-looking placebo patch over the antecubital or hand vein in patients for whom an IV catheter was anticipated. After IV cannulation by the treating nurse, the pain of cannulation was measured on a validated 100-mm visual analogue scale or Wong Baker scale. Outcomes were compared between groups with Mann-Whitney U, Student t, and χ² tests. A sample of 40 patients had 80% power to detect a 13-mm difference in pain scores.
Forty-five patients were randomized to lidocaine/tetracaine patch (22) or placebo (23), and IV cannulation was attempted in 40 of these patients. Mean age was 10 years (SD=4.3), 35% were female patients. The median pain of IV cannulation in the active treatment group (18 mm [interquartile range (IQR) 1 to 40 mm]) was significantly lower than in the placebo group (35 mm [IQR 20 to 59 mm]; P=.04). Adequate pain relief was more common in the active treatment group (75% [95% confidence interval (CI) 53% to 89%] versus 35% [95% CI 18% to 57%]; difference 40% [95% CI 6% to 64%]). The number of successful IV cannulations after the first attempt was similar in both the lidocaine/tetracaine and the placebo groups (90% [95% CI 70% to 97%] versus 85% [95% CI 64% to 95%]; difference 5% (95% CI –21% to 30%).
Application of a topical lidocaine/tetracaine patch resulted in a modest reduction in the pain of IV cannulation in pediatric ED patients and did not alter the rate of successful cannulations.
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^☆: From the Departments of Pediatrics, Epidemiology, and Pharmacy, Egleston Children's Hospital, Emory University School of Medicine, Atlanta, Georgia.

^☆☆: Partially funded by a grant from Iomed Inc., Salt Lake City, Utah.

^★: Reprint requests: William T. Zempsky, MD, Division of Pediatric Emergency Medicine, Connecticut Children's Medical Center, 282 Washington St., Hartford, CT 06106.

^★★: 0022-3476/98/$5.00 + 0 9/22/87380

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Lidocaine iontophoresis for topical anesthesia before intravenous line placement in children☆,☆☆,★,★★

Abstract

Section snippets

Study Design

RESULTS

DISCUSSION

J Control Release

Pain

J Pain Symptom Manage

Topical iontophoretic drug delivery in vivo: historical development, devices and future perspectives

Dermatology

Iontophoresis: an overview of mechanisms and clinical application

Arthritis Care Res

Mini set for iontophoresis for topical analgesia before injection

Int J Clin Pharmacol Ther Toxicol