PURPOSE: To investigate whether a vibrating device applied in a circular motion to the forehead reduces the pain of local anesthetic injection in upper eyelid surgery. DESIGN: Prospective, interventional, cross-over, randomized, controlled clinical trial. PARTICIPANTS: Eighty patients undergoing bilateral upper eyelid surgery under local anesthesia. INTERVENTION: A vibrating device was applied in a circular motion to participants' foreheads while local anesthetic was injected into 1 eyelid. During injection of anesthetic on the contralateral lid, the device was applied to the forehead in static fashion with the vibration switched off (placebo). The order of intervention was randomized. MAIN OUTCOME MEASURES: After both injections had been given, participants were asked to specify their pain ratings for each injection on a scale of 0 to 10, with 0 representing no pain and 10 indicating the worst pain imaginable. Participants were also asked to qualitatively compare the 2 sides. RESULTS: The mean pain scores were 3.3 for the vibration-assisted side and 4.5 for the placebo. This difference was statistically significant (P=0.0003); 73% of participants found the vibrated side to be better than the placebo, with 35% finding it a lot or quite a bit better. CONCLUSIONS:Vibration-assisted anesthesia during upper eyelid surgery has a beneficial effect that is highly statistically significant and is clinically significant in terms of patients' qualitative assessment of pain. Further research is needed to determine whether this constitutes a quantitatively clinically significant improvement in pain management. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
RCT Entities:
PURPOSE: To investigate whether a vibrating device applied in a circular motion to the forehead reduces the pain of local anesthetic injection in upper eyelid surgery. DESIGN: Prospective, interventional, cross-over, randomized, controlled clinical trial. PARTICIPANTS: Eighty patients undergoing bilateral upper eyelid surgery under local anesthesia. INTERVENTION: A vibrating device was applied in a circular motion to participants' foreheads while local anesthetic was injected into 1 eyelid. During injection of anesthetic on the contralateral lid, the device was applied to the forehead in static fashion with the vibration switched off (placebo). The order of intervention was randomized. MAIN OUTCOME MEASURES: After both injections had been given, participants were asked to specify their pain ratings for each injection on a scale of 0 to 10, with 0 representing no pain and 10 indicating the worst pain imaginable. Participants were also asked to qualitatively compare the 2 sides. RESULTS: The mean pain scores were 3.3 for the vibration-assisted side and 4.5 for the placebo. This difference was statistically significant (P=0.0003); 73% of participants found the vibrated side to be better than the placebo, with 35% finding it a lot or quite a bit better. CONCLUSIONS: Vibration-assisted anesthesia during upper eyelid surgery has a beneficial effect that is highly statistically significant and is clinically significant in terms of patients' qualitative assessment of pain. Further research is needed to determine whether this constitutes a quantitatively clinically significant improvement in pain management. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.