Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2018-02-19
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ice Pre-treatment
Participants will hold an exam glove filled with ice to intended biopsy area for 30 seconds prior to preparation and local anesthetic injection.
Ice Pre-treatment
Topical application of ice prior to local anesthetic injection.
Room Temperature Water Pre-Treatment
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.
Room Temperature Water Pre-treatment
Topical application of room-temperature water prior to local anesthetic injection.
Interventions
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Ice Pre-treatment
Topical application of ice prior to local anesthetic injection.
Room Temperature Water Pre-treatment
Topical application of room-temperature water prior to local anesthetic injection.
Eligibility Criteria
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Inclusion Criteria
* 18 years of age or older
* Undergoing vulva biopsy during clinic visit
* Willing and able to comply with study protocol
* Able to understand and provide informed consent
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of Missouri-Columbia
OTHER
Responsible Party
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Kirby Woodall
Resident Physician
Principal Investigators
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Courtney Barnes, MD
Role: PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia
Locations
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Missouri Ob/Gyn Associated
Columbia, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2010101
Identifier Type: -
Identifier Source: org_study_id
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