Intranasal Anesthetic for Chronic Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether lidocaine, an anesthetic, can reduce the pain of Botox® injections for chronic migraines. Participants will have a small piece of cotton with lidocaine placed in their nostrils before receiving injections to assess its effect on discomfort. The study will compare this to using cotton soaked in saline (salt water) as a placebo. Individuals with chronic migraines, experiencing at least 8 headache days per month or significant pain affecting daily life, might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance comfort during migraine treatments.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that intranasal lidocaine is generally safe. In studies, most people experienced only mild side effects, such as a bad taste in the mouth for about 21% of users and nasal discomfort for around 4%. These side effects occurred more frequently than in those who did not use lidocaine. However, no serious problems were reported. Another study found that up to 49.4% of users experienced local irritation, but again, no major issues occurred. Overall, while some mild side effects might happen, intranasal lidocaine is well-tolerated and usually does not cause serious problems.12345
Why are researchers excited about this trial?
Unlike most treatments for chronic migraine, which typically involve oral medications or injectable therapies, this new approach uses intranasal 4% lidocaine. This method of delivery is unique because it offers a non-invasive, rapid action directly targeting nasal pathways that may be involved in migraine mechanisms. Researchers are excited about this treatment because it could provide fast relief without the systemic side effects often associated with traditional oral or injectable migraine medications. Plus, the added flavor in the lidocaine solution might improve patient experience and adherence.
What evidence suggests that this treatment might be an effective treatment for chronic migraine?
Research has shown that lidocaine in a nasal spray can help alleviate migraine pain. In some studies, it reduced headache symptoms by at least half within 15 minutes. Other studies found that 38% of patients experienced pain relief within two hours. It also appears to reduce the need for additional pain medication. In this trial, participants will receive either intranasal lidocaine or a saline placebo to evaluate its effectiveness. While experts continue to discuss lidocaine's efficacy for migraines, many findings suggest it can be a helpful option.13567
Are You a Good Fit for This Trial?
This trial is for adults 18 or older of any gender who have chronic migraines and are scheduled to get Botox® injections for migraine prevention. Participants must be able to give consent and meet certain headache frequency criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intranasal 4% lidocaine or saline before botulinum toxin injections to reduce pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lidocaine
Trial Overview
The study compares whether numbing the inside of the nose with lidocaine before Botox® injections helps reduce pain, versus using a saltwater (saline) solution. Both groups receive standard migraine-preventing Botox® shots.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Intranasal 4% lidocaine: vial with 1ml solution with added flavor
Vial with 1ml liquid containing 0.9% sodium chloride solution with identical flavor
Find a Clinic Near You
Who Is Running the Clinical Trial?
Association of Migraine Disorders
Lead Sponsor
University Otolaryngology
Collaborator
Citations
Intranasal lidocaine for acute migraine: A meta-analysis ... - PMC
Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial.
2.
practicalneurology.com
practicalneurology.com/diseases-diagnoses/headache-pain/intranasal-acute-migraine-treatments/32128/Intranasal Acute Migraine Treatments - - Practical Neurology
Reported outcomes from this trial were pain freedom at 2 hours in 38.0% and pain freedom at 2 hours for doses of Trudehsa taken 2 hours after ...
Intranasal Lidocaine for Treatment of Migraine
-The primary outcome measure was at least 50% reduction of headache within 15 minutes after treatment. Secondary measures in- clude reduction in nausea and ...
Intranasal Lidocaine in Acute Treatment of Migraine
At least 50% reduction in symptom severity was accepted as treatment benefit in the studies. The results of the meta-analysis revealed that intranasal lidocaine ...
Evaluation of efficacy of intra-nasal lidocaine for headache ...
According to these two studies we conclude 10% intranasal lidocaine spray is effective in headache relief with acceptable rate of relapse. Chae et al., (2006) ...
Intranasal lidocaine for acute migraine - PMC
Intranasal lidocaine has been shown to be effective in treating patients with acute migraines; however, its efficacy is still controversial.
7.
neurologyadvisor.com
neurologyadvisor.com/news/intranasal-lidocaine-reduces-pain-and-rescue-medication-in-acute-migraine/Intranasal Lidocaine Reduces Pain and Rescue ...
Intranasal lidocaine has demonstrated efficacy in decreasing the initial pain and reducing the need for rescue medication among those with acute migraine.
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