Intraoral Administration of Botox in Patients With Dentoalveolar Neuropathic Pain
Neuropathic Pain
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- History of continuous dentoalveolar pain with clinically evident positive (hyperalgesia, allodynia) and/or negative (hypoaesthesia, hypoalgesia) signs of trigeminal nerve dysfunction and where other possible pain sources have been ruled out.
- Intractable pain to conventional oral and/or topical pharmacotherapy for neuropathic pain according to the recommendations published by NeuPSIG (Neuropathic Pain Special Interest Group) including anticonvulsants, SNRIs (serotonin and norepinephrine reuptake inhibitors) and/or tricyclic antidepressants.
- Subject consent to participate in the study.
Exclusion Criteria:
- hypersensitive to any onabotulinum toxin preparation or any component in the formulation.
- systemic nerve or muscle disorders
- bleeding disorders
- dysphagia
- breathing problems
- pregnancy or breastfeeding
- previous treatment with botulinum toxin in the last 4 months.
Sites / Locations
- Orofacial Pain CenterRecruiting
Arms of the Study
Arm 1
Experimental
BOTOX
Onabotulinum toxin A is distributed in 50 unit (50U) vacuum-dried powder bottles by Allergan (BOTOX (R)) for reconstitution only with sterile, preservative-free 0.9% Sodium Chloride Injection prior to injection. 1 mL of diluent will be drawn up to obtain a resulting dose of 10 U per 0.2 mL and injected into the vial. The BOTOX(R) will then be gently mixed with the saline by rotating the vial. The date and time of reconstitution will be recorded on the package on the label. BOTOX should be administered within 24 hours after reconstitution and stored in a refrigerator (2-8 °C). Each patient will receive 50 U of onabotulinum toxin A.