title: Use of sodium fluorescein solution for detection of cerebrospinal fluid fistulas: an analysis of 420 administrations and reported complications in Europe and the United States.
abstract: BACKGROUND
  Localization of dural fistulas in the region of the anterior or lateral skull base may be difficult. For many years, a sodium fluorescein solution of 0.5 to 5% (2.5-50 mg) has been administered intrathecally by way of the lumbar space. However, fluorescein is not commercially available for this stated purpose in either Germany or the United States.
  
  
  METHODS
  Retrospectively, 420 fluorescein applications by the authors were retrospectively analyzed. Under the Freedom of Information Act, the United States Federal Drug Administration and the manufactures of fluorescein were queried for adverse reaction reports.
  
  
  RESULTS
  Four hundred twenty fluorescein applications in 305 patients could be evaluated. Mean age of recipients was 46.9 years, ranging from 1 to 82 years. At a concentration of 5% fluorescein, 26 patients on the day of surgery and 69, 37, 34, and 14 patients on days 2 through 4 suffered from minor side effects that may or may not have been related to this drug. Two of these patients had grand mal seizures, which were attributable to simultaneous intrathecal application of contrast medium. All other side effects were thought to be the result of a postspinal headache and related lumbar puncture. At a concentration of 0.5%, the intraoperative intrathecal administration of 0.5 to 2 mL of fluorescein followed by 4 to 5 days of lumbar drainage resulted in some degree of spinal headache without other complications. In both groups, no patient had sequelae longer than 4 weeks. An additional seven complications were reported to the Federal Drug Administration and the fluorescein manufacturers at doses of 100 to 700 mg.
  
  
  CONCLUSIONS
  Complications from intrathecal application of fluorescein appears to be dose dependent. At concentrations of 5%, or preferably lower, side effects are transient. A grand mal seizure can be minimized when following the general cautions of lumbar puncture and dose. The patient should be supervised for 24 hours. A written informed consent from patients for use of fluorescein is recommended.
authors.affiliation: Department of Otorhinolaryngology, Head and Neck Surgery, Facial Plastic Surgery, Hospital St. Elisabeth, St. Elisabeth Str. 23, D 94315 Straubing, Germany. keerlr@klinikum-straubing.de
authors.forename: Rainer
authors.initials: R
authors.lastname: Keerl
authors.forename: Rainer K
authors.initials: RK
authors.lastname: Weber
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Draf
authors.forename: A
authors.initials: A
authors.lastname: Wienke
authors.forename: Steven D
authors.initials: SD
authors.lastname: Schaefer
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002555:Cerebrospinal Fluid; D002559:Cerebrospinal Fluid Rhinorrhea / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D004830:Epilepsy, Tonic-Clonic / Q000139:chemically induced; D005060:Europe; D005260:Female; D005402:Fistula / Q000175:diagnosis; D019793:Fluorescein / Q000008:administration & dosage / Q000009:adverse effects*; D006261:Headache / Q000139:chemically induced; D006801:Humans; D007223:Infant; D007278:Injections, Spinal; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D019291:Skull Base; D014481:United States
chemical_list: D019793:Fluorescein