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ECONOMICS, EDUCATION, AND HEALTH SYSTEMS RESEARCH

A Needle-Free Jet-Injection System with Lidocaine for Peripheral Intravenous Cannula Insertion: A Randomized Controlled Trial with Cost-Effectiveness Analysis

Division of Anesthesiology, Department of APSIC (Anesthesiology, Pharmacology, and Surgical Intensive Care), Geneva University Hospitals, Switzerland

Address correspondence and reprint requests to Christopher Lysakowski, MD, Division of Anesthesiology, Department APSIC, Rue Micheli-du-Crest 24, CH-1211 Geneva 14, Switzerland. Address e-mail to lysakowski.christopher{at}hcuge.ch

	Abstract

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Insertion of a peripheral IV cannula is a common, although painful, procedure. We tested the analgesic efficacy, adverse effects, and cost-effectiveness of a needle-free intradermal drug delivery system (Jet) with lidocaine for the insertion of an IV cannula (18-gauge; dorsum of hand). Four-hundred patients were randomly allocated to one of four groups: (a) no treatment, (b) Jet (J-Tip^®, National Medical Products Inc, CA; $3.0 per device) with 0.5 mL of saline, (3) Jet with 0.5 mL of lidocaine 1%, and (4) Jet with 0.5 mL of lidocaine 2%. Pain was evaluated using a numerical verbal scale (NVS 0–10). A NVS 3 was considered as acceptable in this context. Incremental cost-effectiveness ratios were calculated. Without treatment, 42.4% of patients had a NVS 3, 39.3% with saline, 60.7% with 1% lidocaine (relative risk [RR] compared with no treatment, 0.70; 95% confidence interval [CI], 0.53–0.93), and 86.7% with 2% lidocaine (RR, 0.49; 95% CI, 0.38–0.62). Nineteen and one-half percent of patients had a NVS >3 because of Jet treatment, 13.5% had local hyperemia, and 16.9% had minor local bleeding. Of all Jet treatments, 10.5% were technical failures, and there were 17.6% cannula insertion failures (10.1% without treatment [RR, 1.74; 95% CI, 0.92–3.32]). Compared with no treatment, costs to generate one additional patient with a NVS 3 were $23 with lidocaine 1% and $10 with lidocaine 2%. On insertion of an IV cannula on the back of the hand, 58% of patients report at least moderate pain. Lidocaine-Jet is analgesic; there is dose-responsiveness. However, Jet treatment is not painless, and costs incurred to achieve one success compared with doing nothing are not negligible.

IMPLICATIONS: Insertion of an IV cannula is painful. Four-hundred patients were randomly allocated to test the analgesic efficacy, adverse effects, and cost-effectiveness of the needle-free intradermal drug delivery system (J-Tip^®; Jet). Jet with lidocaine is effective, but its application is not painless. Costs to achieve one patient with no more than moderate pain (numerical verbal scale 3 of 10) on insertion of an IV cannula are $10.

	Introduction

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Insertion of a cannula into a peripheral vein is a common procedure. At Geneva University Hospitals, for instance, more than 120,000 peripheral cannulae have been used during the year 2000. Insertion of an IV cannula is generally considered to be painful. Often, patients perceive it as being extremely uncomfortable; some may even develop a needle phobia (1). Different methods have been proposed to alleviate this pain. However, there is no "gold standard" method, and there is room for the development of innovative analgesic methods that are simple to use, painless, effective with a minimal delay, without adverse effects, and cost-effective.

Needle-free jet-injection systems have been developed for the intradermal administration of vaccines, insulin, heparin, midazolam, ketamine, and local anesthetics (2–8). We evaluated the efficacy, safety, and cost-effectiveness of a Jet-injector with lidocaine for the insertion of a peripheral IV cannula.

	Methods

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After approval by the Institutional Research Advisory Board and the Local Ethical Committee, surgical adult inpatients were invited, after having given written informed consent, to participate in this trial. Exclusion criteria were preoperative analgesic treatment, allergy to local anesthetics, neuropathies, and pregnancy. We tested a Food and Drugs Administration cleared medical single-use jet-injector device (Jet; J-Tip^®, National Medical Products Inc, CA). The device needs to be filled before use. A carbon dioxide gas cartridge generates the pressure that delivers the stream of the local anesthetic, which penetrates into the skin and induces dermal analgesia within seconds (7).

Patients received midazolam 7.5 mg orally 30 min before the procedure. Patients were unaware of treatment allocation. All cannula insertions were performed on the back of the hand and could not be observed by the patient. However, patients could feel manipulations on their hand and hear the noise of the Jet-injector. Both treatment and cannula insertion were verbally announced to the patient. An anesthesiologist prepared the Jet-injector according to the patient’s allocation; this anesthesiologist was not involved in any other procedure. A second anesthesiologist chose a vein, wiped the skin with alcohol, applied the analgesic treatment according to group assignment, and inserted the cannula (18-gauge Optiva 2^®, Johnson & Johnson Medical, San Diego, CA) with a delay of 1 min. He interviewed the patient for pain related to the treatment and to the insertion of the cannula. He also documented immediate and delayed (24 h) local adverse effects. Quality and accessibility of the vein before cannula insertion were rated using a 3 point score (1 = good, 2 = acceptable, and 3 = bad). Patients were asked to rate pain intensity using a numerical verbal scale (NVS) ranging from 0 (no pain) to 10 (excruciating pain). Technical problems related to the manipulation with the Jet-injector and cannula insertion failures were recorded.

Using a computer-generated random number table, patients were prospectively allocated to one of four groups. In Group 1 (no-treatment), a Jet-injector was applied to the patient’s skin in the usual manner but without injection; the noise of the Jet-injector was simulated by a second Jet-injector. The no-treatment control was chosen for three reasons. First, there is no gold standard analgesic treatment in this setting, and thus, to ascertain internal sensitivity of the study, a placebo group (in this case, a no-treatment control) was required (9). Second, we aimed to estimate baseline pain of cannula insertion without any analgesic treatment. Third, in our hospital, analgesia is not routinely used for IV cannulation in adults. In Group 2, Jet-injection was performed with 0.5 mL of physiological saline. This group was used to exclude the idea that the saline injection was analgesic (by comparison with the no-treatment group). In Group 3, Jet-injection was performed with 0.5 mL of lidocaine 1%. In Group 4, Jet-injection was performed with 0.5 mL of lidocaine 2%. Data from the saline, lidocaine 1%, and lidocaine 2% groups were used to test for dose-responsiveness with lidocaine. The anesthesiologist who applied the treatments was unaware of the patient’s assignment and the content of the Jet-injector for Groups 2, 3, and 4 but was not blinded for the no-treatment group.

We estimated the average pain intensity on cannula insertion to be on average 5 on an 11-point NVS. To demonstrate a 50% reduction in pain, 25 patients per group were required ( = 0.05; ß = 0.8; anticipated SD, 3.5). To quantify with more confidence adverse effects and technical problems, and to perform a cost-effectiveness analysis, 400 patients were randomized. The Kruskal-Wallis test was used to compare pain scores of the four treatment groups. In case of a significant result (P < 0.05), Dunn’s posttest was used to narrow down which group was significantly different from another. Dose-responsiveness was assumed when first, both lidocaine 1% and 2% were significantly more analgesic than saline, and second, when lidocaine 2% was significantly more analgesic than lidocaine 1%. There were three pre hoc decisions. First, a NVS 1 was minimal pain. Second, a NVS 3 represented less than moderate pain (10); this degree of discomfort was regarded as acceptable. Third, a NVS >5 was unacceptable. Sensitivity analyses were performed for predefined NVS values (for instance, all patients reporting a NVS 3).

Dichotomous data were analyzed using relative risk (RR) with 95% confidence interval (CI). We initially estimated the annual cost of peripheral vein cannulation assuming our hospital decided to insert all cannulae with a Jet. Second, we quantified the cost incurred in generating one gainer, i.e., a patient who profited from a change in clinical practice from doing nothing (no analgesia for IV cannulation, as is the routine in our hospital) to using Jet with lidocaine 1% or 2%. As direct and indirect costs, we considered the acquisition costs, syringe, and needle to fill the device, lidocaine ampoules, and the IV cannula. We did not take into account the cost for labor because we considered the time for preparation of a Jet device to be insignificant compared with the overall preparation time of an anesthetic. Incremental cost-effectiveness ratios (ICERs) were calculated as the ratio of the difference in cost between two strategies (for instance, Jet with lidocaine 2% compared with no treatment) and the difference in health effects between these strategies (11). Because ICER is the additional cost of generating a unit of health effect, it can be expressed in terms of dollars. Here, health effect was the number of patients who reported pain intensity on cannula insertion that was equal to or less than a predefined NVS value (for instance, NVS 3). Sensitivity analyses were performed for different pain scores, different Jet acquisition costs, and different failure rates. In the case of a technical failure, we assumed that a second device was used for a subsequent cannula insertion. In the case of a cannula insertion failure, we assumed that a second cannula and a second Jet had to be used for a subsequent essay. We assumed that the second attempt was always successful.

	Results

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We randomized 400 patients. Data of four patients were lost. In one, the procedure was performed incorrectly, and four did not understand the procedure (Fig. 1). Of the 296 patients who received a Jet treatment (Groups 2 to 4) and of whom data were available, there was a technical failure in 31 (10.5%). These data were not included in the cost-effectiveness analysis. Average age was 47.3 yr (range, 14 to 88 yr). In all groups, the median quality score of the vein was 1 (range, 1 to 3).

View larger version (16K): [in this window] [in a new window]   Figure 1. Randomized and analyzed patients and reasons for exclusions.

View larger version (53K): [in this window] [in a new window]   Figure 2. Pain on catheter insertion. Numbers on bars are the cumulative numbers of patients who reported the respective pain intensity. NVS = numerical verbal scale.

In a first sensitivity analysis, we assumed that further development had improved the Jet device; thus, technical failures had decreased to 5%. We also assumed that there were only 5% insertion failures without treatment (instead of 10.1%) and only 10% with Jet (instead of 17.6%). When no more than moderate pain (NVS 3) was the end-point, ICER was $20 for Jet with lidocaine 1% compared with no treatment and was still $8.6 for Jet with lidocaine 2%. In a second sensitivity analysis, we assumed that Jet acquisition cost was only $1. For no more than moderate pain (NVS 3), ICER was $8.6 for Jet with lidocaine 1% compared with no treatment and $3.8 for Jet with lidocaine 2%. In a third sensitivity analysis, we combined all assumptions from the first and the second sensitivity analysis as follows: Jet acquisition cost, $1; technical failures, 5%; insertion failures without treatment, 5%; and with Jet, 10%. For no more than moderate pain on cannula insertion (NVS 3), ICER was $7.7 for Jet with lidocaine 1% compared with no treatment and $3.4 for Jet with lidocaine 2%.

	Discussion

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Pain related to the insertion of a peripheral venous cannula is a minor medical problem. However, this procedure is distressing for most patients; approximately 60% of those who did not receive any analgesia reported moderate to severe pain. Most patients will experience that pain at least once during a hospital stay. Lidocaine 2% reduced the pain scores by more than 50%, and it was significantly more analgesic than lidocaine 1%. Thus, the J-Tip^® injector with lidocaine is effective, and there is evidence of dose-responsiveness. For a NVS 3, the absolute risk reduction with lidocaine 2% compared with no treatment was approximately 40%; less than 3 patients need to be treated for 1 not to report more than moderate pain who would have done so had they not received any analgesia. This degree of efficacy may be perceived as being relevant in this context.

However, there were three major drawbacks with the Jet device. First, treatment with Jet was not painless; one-fifth of the patients reported at least moderate pain because of the treatment itself. Second, the number of technical failures was large; in one-tenth of all applications, the device could not be used. We may only assume that further improvement of the device and perhaps training of those who use it will lead to a decrease in this frequent failure rate. Third, there was some evidence that cannula insertion may be more difficult after use of the device. This may be because of the high-pressure injection of the local anesthetic with subsequent local edema and minor bleeding.

Knowing that Jet with lidocaine decreases pain related to cannula insertion begs the questions as to how this intervention compares with other analgesic methods. There have been numerous attempts to reduce pain on IV cannulation. Among those is infiltration of the skin with a 25-gauge needle (7) or a 30-gauge needle (12), with lidocaine 1% (13) or 2% (12), with or without sodium bicarbonate (14), and with chloroprocaine 2% (15). Others have tested the topical administration of EMLA^® cream (16). Although these methods are effective to some extent, they do have disadvantages. The infiltration of the skin, for instance, is not painless, and there is a risk, albeit small, that the medical staff performing the infiltration may become contaminated through self-injury with the needle. For the best analgesic efficacy with the EMLA^® cream, there must be a delay of at least 60 minutes between the administration of the cream and insertion of the cannula (16). Also, some of the studies reported on contradictory results (12,15,17). Finally, this variety of analgesic methods that have been tested suggests that there is no gold standard intervention in this setting. To ensure internal sensitivity of our study, we therefore had to choose a no-treatment group as a control (9).

Cost-effectiveness is another issue. The Geneva University Hospital would have to spend more than $500,000 each year if it decided to use the Jet with lidocaine 2% for all peripheral cannula insertions as a routine in adults. For rational decision-making, it is important to estimate the costs incurred to generate one patient who is profiting from a change in clinical practice from doing nothing (i.e., from not using any analgesic treatment) to applying the Jet. Thus, the main question is, is it worth spending $11 to achieve an additional patient with minimal pain and $10 to achieve an additional patient with moderate pain (Table 2)? We included both technical failures and insertion failures in our cost-effectiveness analysis. Neither of them seemed to be big cost drivers relative to the cost of the J-Tip^® and the material to prepare the Jet (syringe, needle, and lidocaine). When, in a best case scenario, the rates of technical and insertion failures were halved and the assumption was made that acquisition cost of one device was only $1, the cost to generate an additional patient with no more than moderate pain by changing from doing nothing to the Jet with lidocaine 2% was still $3.4. In times where health care providers are increasingly dealing with patients’ quality of life and satisfaction, this amount may be worthwhile to spend to achieve a better outcome, even for a minor medical problem. One way to further decrease extra costs would be to identify patients who are most likely to profit from an adequate analgesia for cannula insertion, e.g., children, patients with needle phobia, or those who require a cannula insertion very frequently. The Jet device could then be used selectively in these patients, although the cost to generate one gainer would stay the same.

	Acknowledgments

 
Martin R. Tramèr is a recipient of a PROSPER (Program for Social Medicine, Preventive and Epidemiological Research) grant from the Swiss National Research Foundation (No. 3233–051939.97/2).

	Footnotes

 
National Medical Products Inc, California, provided the jet devices.

None of the authors received a direct salary from the company that provided the jet devices or a competing company, and none of the authors has an equity interest in, a continuing consultancy with, or membership on the scientific advisory board of such a company, or a related patent pending. The authors’ independence in designing the study, the interpretation of the data, and writing the report, and decisions regarding publication were ensured.

	References

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Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999