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

Completed · Phase 4 · Has a placebo group

Conditions studied: Dental Anesthesia, Anesthesia, Local, Anesthesia, Reversal

In brief

The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.

Key facts

Study ID: NCT01474382
Run by: Novocol Pharmaceutical of Canada, Inc.
People needed: 150
Starts: 2012-02-01
Expected to finish: 2014-08-01
Last updated by the study team: 2014-08-29

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female, 2 to 5 years of age
Sufficiently healthy as determined by the Investigator to receive routine dental care
Requires a restorative procedure (restoration/filling) in a single quadrant of the mouth
Requires local anesthesia with lidocaine 2% with 1:100,000 epinephrine administered by submucosal injection
For subjects undergoing mandibular procedures, require an inferior alveolar nerve block for the restorative procedure
Dental procedure(s) completed within 60 minutes of injection of local anesthetic
For subjects 4 and 5 years of age, can be trained in standardized lip/tongue palpation procedure and pFAB
Subjects who are trainable in pFAB and standardized lip/tongue palpation procedure have either:
normal pFAB at baseline prior to administration of local anesthetic and
at least one abnormal function (smiling, speaking, drinking or drooling) at the completion of the dental procedure OR
normal lip sensation at baseline prior to administration of local anesthetic and
numbness of the relevant lip quadrant at completion of the dental procedure
Subjects give written or verbal assent, as capable and appropriate, and parent(s) or legal guardian(s) give written informed consent

You may not qualify if…

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

Where it is running

University of California, San Francisco — San Francisco, California, United States
Indiana University School of Dentistry — Indianapolis, Indiana, United States
Nationwide Children's Hospital — Columbus, Ohio, United States
University of Pennsylvania School of Dental — Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Dental Medicine — Pittsburgh, Pennsylvania, United States
Jean Brown Research — Salt Lake City, Utah, United States
Center for Pediatric Dentistry — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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