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| Name | Class |
|---|---|
| University Otolaryngology | UNKNOWN |
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People find the injections used in onabotulinumtoxinA (Botox®) uncomfortable. This study will test whether putting a small piece of cotton soaked with 4% lidocaine (a numbing medicine) inside the front of each nostril for 5 minutes before the injections reduces injection pain compared with cotton soaked in saline (salt water).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Intranasal 4% lidocaine: vial with 1ml solution with added flavor |
|
| Saline | Placebo Comparator | Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA prophylaxis with Lidocaine | Procedure | The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (lidocaine) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall patient-reported injection pain | Overall patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between 4% lidocaine versus 0.9% saline. | Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported injection pain at each region | Comparison of patient-reported injection pain [0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale] between regions by treatment. Facial anatomical regions include:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frederick A Godley, MD | Contact | 401-274-2300 | Rick@migrainedisorders.org | |
| Leigh Serth | Contact | Leigh@migrainedisorders.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Otolaryngology | Recruiting | East Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21883197 | Background | Aurora SK, Winner P, Freeman MC, Spierings EL, Heiring JO, DeGryse RE, VanDenburgh AM, Nolan ME, Turkel CC. OnabotulinumtoxinA for treatment of chronic migraine: pooled analyses of the 56-week PREEMPT clinical program. Headache. 2011 Oct;51(9):1358-73. doi: 10.1111/j.1526-4610.2011.01990.x. Epub 2011 Aug 29. | |
| 20958294 | Background |
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This is a pilot study of patients seen in a single clinic.
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| OnabotulinumtoxinA prophylaxis with Saline | Procedure | The onabotulinumtoxinA prophylaxis procedure is the modified PREEMPT protocol consisting of 56 injections; 200 Units. The solution from the vial (Saline) will be dripped onto 2 small pieces of cotton. One piece of cotton will be placed in the anterior portion of the nasal cavity on each side of the nose. The cotton will be removed after 5 minutes. The clinician will then perform the various series of injections while assessing pain of the injection site following each series of injections. |
|
| At Study Visit 1 and 12 weeks later at Study Visit 2. Ratings will occur within 1 minute of injection for each injection region during the procedure. |
| Blumenfeld A, Silberstein SD, Dodick DW, Aurora SK, Turkel CC, Binder WJ. Method of injection of onabotulinumtoxinA for chronic migraine: a safe, well-tolerated, and effective treatment paradigm based on the PREEMPT clinical program. Headache. 2010 Oct;50(9):1406-18. doi: 10.1111/j.1526-4610.2010.01766.x. |
| 18328199 | Background | Comite S, Greene A, Cieszynski SA, Zaroovabeli P, Marks K. Minimizing discomfort during the injection of Radiesse with the use of either local anesthetic or ice. Dermatol Online J. 2007 Jul 13;13(3):5. |
| 23957989 | Background | Hamilton HK, Arndt KA. Techniques for minimizing pain with injections. J Am Acad Dermatol. 2013 Sep;69(3):e117. doi: 10.1016/j.jaad.2013.05.024. No abstract available. |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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