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This study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.
To diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. Prior to biopsy, the skin is cleansed and injected with a numbing solution. These injections can be quite painful in this sensitive area.
Ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. However, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues.
The purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ice Pre-treatment | Experimental | Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection. |
|
| Room Temperature Water Pre-Treatment | Placebo Comparator | Participants will hold an exam glove filled with room temperature water to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ice Pre-treatment | Other | Topical application of ice prior to local anesthetic injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-injection Pain Score | Patient's self-reported visual analogue pain scale (100 millimeter) after injection of local anesthetic. Range from 0 to 100 mm, with 0 being least amount of pain and 100 being the most amount of pain. | Immediately after local anesthetic injection |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure satisfaction score | Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with the procedure. Range form 0mm to 100mm with 0 being the least satisfied and 100 being the most satisfied. | Immediately after procedure |
| Post-procedure anxiety score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Courtney Barnes, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Missouri Ob/Gyn Associated | Columbia | Missouri | 65202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11359502 | Background | Kuwahara RT, Skinner RB. Emla versus ice as a topical anesthetic. Dermatol Surg. 2001 May;27(5):495-6. doi: 10.1046/j.1524-4725.2001.00343.x. | |
| 12561049 | Background | Chan HH, Lam LK, Wong DS, Wei WI. Role of skin cooling in improving patient tolerability of Q-switched Alexandrite (QS Alex) laser in nevus of Ota treatment. Lasers Surg Med. 2003;32(2):148-51. doi: 10.1002/lsm.10112. |
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| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Participants will be randomly assigned to either pre-treatment with ice inside a sterile glove or with room-temperature water inside an exam glove.
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| Room Temperature Water Pre-treatment | Other | Topical application of room-temperature water prior to local anesthetic injection. |
|
Patient's self-reported visual analogue scale (100 millimeter) score for anxiety level about having another vulvar biopsy in the future. Range from 0mm to 100mm, with 0 being the least anxious and 100 being the most anxious about a future procedure. |
| Immediately after procedure |
| Post-procedure pain control score | Patient's self-reported visual analogue scale (100 millimeter) for satisfaction with pain control during procedure. Range from 0mm to 100mm with 0 being the least satisfied with pain control and 100mm being the most satisfied with pain control. | Immediately after procedure |
| Post-biopsy pain score | Patient's self-reports visual analogue pain scale (100 millimeter) score immediately after biopsy. Range from 0mm to 100mm, with 0 being the the least pain and 100 being the most pain. | Immediately after procedure. |
| 16754218 | Background | Goel S, Chang B, Bhan K, El-Hindy N, Kolli S. "Cryoanalgesic preparation" before local anaesthetic injection for lid surgery. Orbit. 2006 Jun;25(2):107-10. doi: 10.1080/01676830600675392. |
| 17567343 | Background | Leff DR, Nortley M, Dang V, Bhutiani RP. The effect of local cooling on pain perception during infiltration of local anaesthetic agents, a prospective randomised controlled trial. Anaesthesia. 2007 Jul;62(7):677-82. doi: 10.1111/j.1365-2044.2007.05056.x. |
| 23617804 | Background | Dixit S, Lowe P, Fischer G, Lim A. Ice anaesthesia in procedural dermatology. Australas J Dermatol. 2013 Nov;54(4):273-6. doi: 10.1111/ajd.12057. Epub 2013 Apr 26. |
| 24379869 | Background | Ghaderi F, Banakar S, Rostami S. Effect of pre-cooling injection site on pain perception in pediatric dentistry: "A randomized clinical trial". Dent Res J (Isfahan). 2013 Nov;10(6):790-4. |
| 24945871 | Background | Lindsell LB, Miller DM, Brown JL. Use of topical ice for local anesthesia for intravitreal injections. JAMA Ophthalmol. 2014 Aug;132(8):1010-1. doi: 10.1001/jamaophthalmol.2014.1397. No abstract available. |
| 26379379 | Background | Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11. |
| 26957683 | Background | Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846. |
| 28559708 | Background | Bhadauria US, Dasar PL, Sandesh N, Mishra P, Godha S. Effect of injection site pre-cooling on pain perception in patients attending a dental camp at Life Line Express: a split mouth interventional study. Clujul Med. 2017;90(2):220-225. doi: 10.15386/cjmed-694. Epub 2017 Apr 25. |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |