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Randomised Controlled Trials: examples

clinmed/1999120016v1 (December 29, 1999)
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An open prospective randomised trial to reduce the pain of blood glucose testing. Ear vs Thumb.

Simon D. Carley, Carol Libetta, Brian Flavin, John Butler, Nam Tong, and Ian A. Sammy

Abstract Objective: To compare the pain of testing when taking a blood glucose sample from either the ear or the thumb. Design: Open unblinded prospective randomised controlled trial. Setting: The Emergency Medicine department of a university-affiliated hospital. Subjects: 60 patients; aged  16 requiring a random blood glucose test. Patients were excluded if they were dysphasic, less than Alert on the AVPU scale, known to have a bleeding disorder or if they had paraesthesia, anaesthesia or lesions at any of the test sites. Main Outcome measures: 1) Self reported pain by 100mm visual analogue scale; 2) Success rate by intention-to-test Results: 60 patients completed the protocol. The medican pain score for ear sampling was 2mm as compared to 8.5mm in the thumb group, this was statistically significant (p=0.01). There were 5 failures in the ear group as compared to 2 in the thumb group (p=0.42) Conclusions: The pain of lancet testing at both sites is low. Emergency lancet skin puncture in adults is likely to be less painful if carried out in the ear rather than the thumb. Key words. Blood glucose testing, pain, lancet.





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