Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia

Inclusion Criteria

• Subjects must meet all of the following criteria prior to enrollment in the study:
• Provide written informed consent and HIPAA authorization. Residents of California must also review and sign the California Subject Bill of Rights.
• Male or female ≥18 years of age.
• Predetermined need from a physician for diagnostic procedure or surgery on or through the nasal mucous membranes of either one or two nostrils that merits the use of anesthesia.
• Ability to feel pain sensation normally in the nasal mucous membranes, as verified via Von Frey 5.88 monofilament testing
• Ability to clearly communicate pain and sensation of the nasal mucous membranes.

Exclusion Criteria

• Has a known allergy to any ester based anesthetics including cocaine, procaine, tetracaine, chlorprocaine, dibucaine, or benzocaine and/or any other compounds of the drugs and/or devices that are part of this protocol. (Amide based or other non-ester based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prolicaine, and Articaine).
• Has a history of abuse of controlled substances, nasal or otherwise, or has damage to the nasal space, that in the opinion of the investigator might interfere with the ability of the subject or the investigator to judge anesthesia from the trial drug.
• Has used any investigational drug(s) within 30 days preceding the randomization.
• Is pregnant or is a nursing mother
• Women of childbearing potential (WOCBP) and male partners of WOCBP who are not willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Contraceptive practices must extend for women at least 30 days and for male partners of WOCBP at least 90 days after the last dose of investigational product in such a manner that the risk of pregnancy or risk to a pregnancy is minimized.
• Is 5.0 mEq/L
• Serum ALT, AST, and bilirubin exceeding 2X ULN for the lab's reference values
• Cardiac enzymes above the range of normal
• Coagulation studies that in the opinion of the investigator would be cause for the subject to be excluded from the study.
• Positive urine pregnancy test at screening or Day 1
• Positive urine drug test at screening or Day 1 without prior medically-necessary use of controlled substances (for example, benzodiazepines for anxiety)
• Subjects is a member of the Investigational Team, including Investigators or Sub-Investigators, or their immediate family.

A one-time retest is permitted for any blood test if the original sample was hemolyzed.