Pain From onabotulinumtoxinA Injections
Conditions
Brief summary
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).
Interventions
PROCEDUREonabotulinumtoxinA prophylaxis with Lidocaine
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.
PROCEDUREOnabotulinumtoxinA prophylaxis with Saline
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.
Sponsors
Association of Migraine Disorders
University Otolaryngology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 years * Any gender * Able to provide informed consent * Meets clinical criteria for onabotulinumtoxinA for chronic migraine (minimum of 2 days of disability per month due to facial or headache pain, or 8 headache days per month, or more than 15 headaches per month) * Scheduled for modified PREEMPT injections at the clinical site
Exclusion criteria
* Aged \< 18 years * Trigeminal neuralgia, cluster headache, or other primary headache disorders as dominant diagnosis * Not able to provide informed consent * Known allergy/hypersensitivity to lidocaine or amide anesthetics * Pregnancy/lactation * Inability to tolerate intranasal nasal cotton pledgets * Significant nasal pathology at placement site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall patient-reported injection pain | Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2. | Overall patient-reported injection pain \[0 (no pain) -10 (worse pain possible) Likert/Numeric Rating Scale\] between 4% lidocaine versus 0.9% saline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported injection pain at each region | 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. | 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: 1. Forehead/glabellar (frontalis + corrugator/procerus) 2. Right temple (temporalis) 3. Left temple (temporalis) 4. Posterior scalp/neck (occipitalis, cervical paraspinals, trapezius combined) |
Countries
United States
Contacts
CONTACTFrederick A Godley, MD
CONTACTLeigh Serth
Outcome results
None listed