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IV Start Folder - Gebauer Company

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Clinical evidence for choosing Pain Ease<br />

Use a topical anesthetic to control the pain associated<br />

with <strong>IV</strong> starts, instead of another injection.<br />

“Cannulation on first attempt was more often successful with the<br />

use of vapocoolant spray (85.0%) than with placebo (62.5%)...”<br />

Farion K, Splinter K, Newhook K, Gaboury I, Splinter W. The effect of vapocoolant<br />

spray on pain due to intravenous cannulation in children: a randomized controlled trial.<br />

Canadian Medical Association Journal, July 1, 2008; 179 (1), pp 31-6.<br />

“It causes less interference with cannulation than lidocaine; even<br />

though it freezes the skin, no venoconstriction occurs and, unlike<br />

lidocaine, no tissue distortion occurs.”<br />

Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain:<br />

a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep; 37(6): 656-8.<br />

“Following application of the local anesthetic, there was a difference in<br />

venous visibility between groups; the ethyl chloride spray having no<br />

effect whilst the intradermal lidocaine impaired it. Ethyl chloride had<br />

no effect on the ease of insertion of the cannula whilst intradermal<br />

lidocaine increased the cannulation difficulty...”<br />

Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain:<br />

a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep; 37(6): 656-8.<br />

Unclassified Prescription<br />

Medical Device<br />

The FDA has designated <strong>Gebauer</strong>’s<br />

Pain Ease ® as a prescription only (Rx)<br />

The FDA has determined that<br />

each of the <strong>Gebauer</strong> <strong>Company</strong><br />

medical device. family of skin refrigerants is<br />

substantially equivalent (SE)<br />

This designation to means each other that in Pain terms Ease of<br />

can be sold to and efficacy. purchased Therefore, by these any clinical<br />

references and abstracts are<br />

healthcare practitioner who is licensed<br />

relevant to all <strong>Gebauer</strong> <strong>Company</strong><br />

by the state in which skin refrigerants. they practice.<br />

• Healthcare practitioners include doctors,<br />

chiropractors, physical therapists,<br />

nurses, dentists, etc.<br />

• Any healthcare practitioner should be<br />

able to purchase prescription devices<br />

without restriction.<br />

• Pain Ease may be purchased by any<br />

patient who receives a prescription or<br />

“other order”* from any licensed<br />

healthcare practitioner<br />

*An “other order” is defined as an instruction from<br />

a healthcare practitioner to use a prescription device.<br />

“The use of lignocaine produced more failed cannulations than in<br />

the other groups, although the difference did not achieve significance<br />

at P

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