Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients

Exclusion Criteria

• •Weight less than 10 kg
• •Weight less than 15 kg if 4 or 5 years of age
• •History or presence of any condition that contraindicates routine dental care or use of local anesthetic
• •Requires more than ¼ cartridge of local anesthetic if weight is ≥ 10 kg and \< 15 kg, more than ½ cartridge of local anesthetic if weight is ≥ 15 kg and \< 30 kg, and more than 1 cartridge of local anesthetic if weight is ≥ 30 kg, excluding supplemental injections
• •Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, nitrous oxide or topical benzocaine
• •Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
• •Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
• •Any use of commercial OraVerse™ within 30 days of study drug administration
• •Use of opioid or opioid-like analgesics within 24 hours prior to administration of local anesthetic
• •Requires the use of local anesthetic other than lidocaine 2% with 1:100,000 epinephrine to perform the scheduled dental procedure
• •Requires the use of general anesthesia or sedatives except for nitrous oxide to perform the scheduled dental procedure
• •Any condition which in the opinion of the Investigator increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol