Topical Intranasal Anesthetic Block for Reducing the Pain of Botulinum Toxin Injections for Chronic Migraine

ConditionPain From onabotulinumtoxinA Injections

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAssociation of Migraine Disorders

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

onabotulinumtoxinA prophylaxis with Lidocaine
Procedure/Surgery
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.
OnabotulinumtoxinA prophylaxis with Saline
Procedure/Surgery
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.

Treatment groups

18 Participants

are divided into 2 treatment groups

Group A: LidocaineExperimental treatment 1 intervention

Group B: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2.

Secondary outcomes

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: 1. Forehead/glabellar (frontalis + corrugator/procerus) 2. Right temple (temporalis) 3. Left temple (temporalis) 4. Posterior scalp/neck (occipitalis, cervical paraspinals, trapezius combined)

Time frame

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Association of Migraine Disorders

Lead sponsor

University Otolaryngology

Collaborator

Source ClinicalTrials.gov

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