The Effect of Vibration on Pain during Intravenous Injection of Propofol: A Randomized, Controlled, Single-blinded Study
Lyahn Hwang, M.D., David Nash, M.D., Adam Yedlin, M.D., Nicolas Greige, B.S., Jessie Larios-Valencia, B.S., Curtis Choice, M.D., Aravind Pothula, M.D..
Montefiore Medical Center, Bronx, NY, USA.
BACKGROUND: Pain is a common side effect of intravenous injection of propofol. We conducted a randomized, prospective, single-blinded controlled trial to assess the efficacy of vibration analgesia on pain during propofol infusion in ambulatory surgery. METHODS: After approval was obtained from the institutional review board and the United States Food and Drug Administration (FDA) Clinical Trials Registry, 100 patients undergoing elective ambulatory surgery with general anesthesia were randomized into two groups. A control group (n=50) consisted of patients who received infusion of propofol without vibration analgesia. A treatment group (n=50) consisted of patients who received infusion of propofol with vibration analgesia using the BuzzyTM device. Pain was assessed utilizing a four-point pain manifestation scale scored by two independent, blinded observers. RESULTS: Participants in the treatment group with vibration analgesia were 0.47 times less likely (95% CI: 0.24 -0.94, p=0.03) to experience any pain than the control group. The median summative pain score in the treatment group was significantly less than that of the control group (1[IQR: 1-2] vs. 2 [IQR: 2-4], p<0.01) amongst participants that experienced any pain. Agreement between the two blinded observers regarding pain scores was excellent with κw=0.82 (p<0.001). Age, sex, BMI, needle location or size, and medication doses did not differ significantly between the two groups. CONCLUSIONS: To our knowledge, this is the first clinical trial demonstrating the efficacy of vibration analgesia in reducing the incidence and severity of painful propofol injection. Vibration is a low-risk, reusable, and low-cost modality and should be considered as an adjunct during the induction of general anesthesia.
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