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

Conditions

• Pain From onabotulinumtoxinA Injections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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).

Key Dates

Start date

Mar 3, 2026

Status verified

May 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

18 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

• Experimental: Lidocaine
  Intranasal 4% lidocaine: vial with 1ml solution with added flavor
• Placebo Comparator: Saline
  Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor

Primary Outcome Measure

Overall patient-reported injection pain [ Time Frame: Immediately before and immediately following the procedure at Study Visit 1 and again 12 weeks later at Study Visit 2. ]

Central Contacts

• Frederick A Godley, MD
  401-274-2300
  [email protected]
• Leigh Serth
  [email protected]

Locations (1)

Find similar trials in East Providence, RI