IV Start Folder - Gebauer Company
IV Start Folder - Gebauer Company
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