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| Name | Class |
|---|---|
| Winnipeg Regional Health Authority | OTHER |
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To compare the efficacy of topical tapping vs vibration in lowering pain scores for periocular anesthesia injections.
Participants will be selected from 3 local oculoplastics surgeons' procedural slates during the study period. Eligible participants are those who will be undergoing bilateral eye procedures. They will be randomized into one of two groups: Group A will receive tapping on their forehead for their first eye injection of local anesthesia, and then vibration to their forehead for the second eye. Group B will receive the reverse. Pain scores will be aggregated and an average taken to help determine which method is superior. The vibration assist device (variety of facial massagers are available on Amazon for roughly $16-20CDN) is being considered in addition to the current standard of tapping or no tactile distraction at all during the injection of local anesthetic. The 11-point pain Visual Analog Scale will be used to help grade pain experience after each eye is frozen. To help qualify, if there is a difference, the patient will be asked if they felt one technique was better than the other by a little, quite a bit, or a lot.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Tap then Vibrate | Active Comparator | Tapping for the first eye/side during infiltration of local anesthetic, then vibration for the second eye. |
|
| Group B: Vibrate then Tap | Experimental | Vibration first, then tapping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration | Device | Vibration Assist Device, held to the forehead |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Reduction in Tapping vs Vibration distraction techniques in peri-ocular local anesthesia | How effective each intervention was in reducing the pain of peri-ocular local anesthesia, as graded on an 11-point Visual Analog Pain Scale (from 0-10 where 10/10 pain is the worst and 0/10 pain is no pain at all) | Immediately after both eyes receive local anesthetic |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Pain Reduction | If there was a difference, subjective qualitative grading of how much difference: a little bit, quite a bit, or a lot | Immediately after both eye receive local anesthetic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yen Minh Cung, MD | University of Manitoba, Dept of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misericordia Health Centre | Winnipeg | Manitoba | R3C 1A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30664129 | Background | Gostimir M, Hussain A. A Systematic Review and Meta-analysis of Methods for Reducing Local Anesthetic Injection Pain Among Patients Undergoing Periocular Surgery. Ophthalmic Plast Reconstr Surg. 2019 Mar/Apr;35(2):113-125. doi: 10.1097/IOP.0000000000001209. | |
| 18784857 | Background | Aminabadi NA, Farahani RM, Balayi Gajan E. The efficacy of distraction and counterstimulation in the reduction of pain reaction to intraoral injection by pediatric patients. J Contemp Dent Pract. 2008 Sep 1;9(6):33-40. |
| Label | URL |
|---|---|
| Specific vibration assist device used in the study | View source |
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After 5 years the hard copies of data collection sheets and master list will be shredded.
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Each patient will receive both interventions and serve as their own comparator.
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The participant and surgeon was not made aware of which intervention the participant would receive first until the time of the procedure. Randomization was made at the time of the procedure.
| Tapping | Other | Tapping on the forehead |
|
| 23985640 | Background | Strazar AR, Leynes PG, Lalonde DH. Minimizing the pain of local anesthesia injection. Plast Reconstr Surg. 2013 Sep;132(3):675-684. doi: 10.1097/PRS.0b013e31829ad1e2. |
| 20883298 | Background | Babamiri K, Nassab R. The evidence for reducing the pain of administration of local anesthesia and cosmetic injectables. J Cosmet Dermatol. 2010 Sep;9(3):242-5. doi: 10.1111/j.1473-2165.2010.00503.x. |
| 31513234 | Background | Govas P, Kazi R, Slaugenhaupt RM, Carroll BT. Effect of a Vibratory Anesthetic Device on Pain Anticipation and Subsequent Pain Perception Among Patients Undergoing Cutaneous Cancer Removal Surgery: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2019 Dec 1;21(6):480-486. doi: 10.1001/jamafacial.2019.0733. |
| 30666086 | Background | Ing EB, Philteos J, Sholohov G, Kim DT, Nijhawan N, Mark PW, Gilbert J. Local anesthesia and anxiolytic techniques for oculoplastic surgery. Clin Ophthalmol. 2019 Jan 10;13:153-160. doi: 10.2147/OPTH.S188790. eCollection 2019. |
| 5320816 | Background | Melzack R, Wall PD. Pain mechanisms: a new theory. Science. 1965 Nov 19;150(3699):971-9. doi: 10.1126/science.150.3699.971. No abstract available. |
| 11849262 | Background | Chen BK, Eichenfield LF. Pediatric anesthesia in dermatologic surgery: when hand-holding is not enough. Dermatol Surg. 2001 Dec;27(12):1010-8. doi: 10.1046/j.1524-4725.2001.01854.x. |
| 15530291 | Background | Smith KC, Comite SL, Balasubramanian S, Carver A, Liu JF. Vibration anesthesia: a noninvasive method of reducing discomfort prior to dermatologic procedures. Dermatol Online J. 2004 Oct 15;10(2):1. |
| 10411170 | Background | McKinlay JR, Hofmeister E, Ross EV, MacAllister W. EMLA cream-induced eye injury. Arch Dermatol. 1999 Jul;135(7):855-6. doi: 10.1001/archderm.135.7.855. No abstract available. |
| 11260545 | Background | Reed ML. Surgical pearl: mechanoanesthesia to reduce the pain of local injections. J Am Acad Dermatol. 2001 Apr;44(4):671-2. doi: 10.1067/mjd.2001.110641. No abstract available. |
| 10352653 | Background | Katz J, Melzack R. Measurement of pain. Surg Clin North Am. 1999 Apr;79(2):231-52. doi: 10.1016/s0039-6109(05)70381-9. |
| 11690728 | Background | Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9. |
| 20303597 | Result | Fayers T, Morris DS, Dolman PJ. Vibration-assisted anesthesia in eyelid surgery. Ophthalmology. 2010 Jul;117(7):1453-7. doi: 10.1016/j.ophtha.2009.11.025. Epub 2010 Mar 19. |
| 22001341 | Result | Sharma P, Czyz CN, Wulc AE. Investigating the efficacy of vibration anesthesia to reduce pain from cosmetic botulinum toxin injections. Aesthet Surg J. 2011 Nov;31(8):966-71. doi: 10.1177/1090820X11422809. Epub 2011 Oct 14. |