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JOURNAL OF MAXILLOFACIAL TRAUMA
Rivista di Traumatologia Maxillofacciale
Official Journal of the International Society of Maxillofacial Trauma
Journal of Maxillofacial Trauma 2012 Aprile;1(1):13-9
A tolerability study in orthognathic surgery patients of intranasal cyanocobalamin spray: a potential treatment for acute peripheral nerve injury
Phillips C. 1, Blakey G. 2, Essick G. K. 3
1 Department of Orthodontics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;
2 Department of Oral and Maxillofacial Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;
3 Professor, Department of Prosthodontics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA
Aim. The aim of this paper was to assess the safety of intranasal cyanocobalamin (vitamin B12) spray used after a general anesthesia surgical procedure involving facial osteotomies and nasal intubation and to obtain preliminary data on the ameliorative effect of B12 on iatrogenic peripheral nerve injury.
Methods. Twenty-seven subjects, 13 to 50 years of age, scheduled for a bilateral sagittal split osteotomy were enrolled in an open-label study. The weekly dose of the study medication was self-administered at home from before surgery to 6 months after surgery. Five standard serum B12 assays were obtained. Contact detection thresholds (CDTs) using von Frey hairs were obtained on the right and left sides of the chin. The maximum impairment was used as the outcome at each follow-up visit. A linear mixed effect model was fit to obtain estimates of the contact detection impairment after controlling for the effect of the change in serum B12 levels from baseline.
Results. The average change in serum B12 levels from baseline to each post-surgery visit exceeded 400 pg/mL. Contact detection impairment at 3 and 6 months after surgery was reduced noticeably after adjustment for the change in B12 serum levels from baseline. A grade 1 allergic adverse event following the 16th and 17th weekly dose, attribution unknown, was reported by one subject.
Conclusion. Intranasal B12 spray is well tolerated when self-administered after orthognathic surgery. The decrease in contact detection impairment with higher levels of change in serum levels of vitamin B12 was sufficiently positive to warrant further investigation of the potential effect of B12 as an ameliorative treatment following acute peripheral nerve injury.