title: An evaluation of 10 percent and 20 percent benzocaine gels in patients with acute toothaches: efficacy, tolerability and compliance with label dose administration directions.
abstract: BACKGROUND
  The authors evaluated the efficacy and tolerability of 10 percent and 20 percent benzocaine gels compared with those of a vehicle (placebo) gel for the temporary relief of toothache pain. They also assessed the compliance with the label dose administration directions on the part of participants with toothache pain.
  
  
  METHODS
  Under double-masked conditions, 576 participants self-applied study gel to an open tooth cavity and surrounding oral tissues. Participants evaluated their pain intensity and pain relief for 120 minutes. The authors determined the amount of gel the participants applied.
  
  
  RESULTS
  The responders' rates (the primary efficacy parameter), defined as the percentage of participants who had an improvement in pain intensity as exhibited by a pain score reduction of at least one unit on the dental pain scale from baseline for two consecutive assessments any time between the five- and 20-minute points, were 87.3 percent, 80.7 percent and 70.4 percent, respectively, for 20 percent benzocaine gel, 10 percent benzocaine gel and vehicle gel. Both benzocaine gels were significantly (P ≤ .05) better than vehicle gel; the 20 percent benzocaine gel also was significantly (P ≤ .05) better than the 10 percent benzocaine gel. The mean amount of gel applied was 235.6 milligrams, with 88.2 percent of participants applying 400 mg or less.
  
  
  CONCLUSIONS
  Both 10 percent and 20 percent benzocaine gels were more efficacious than the vehicle gel, and the 20 percent benzocaine gel was more efficacious than the 10 percent benzocaine gel. All treatments were well tolerated by participants. Practical Implications. Patients can use 10 percent and 20 percent benzocaine gels to temporarily treat toothache pain safely.
authors: Division of Pharmacology and Therapeutics, Department of Oral Surgery and Pharmacology, School of Dental Medicine, University of Pennsylvania, 240 S. 40th St., Philadelphia, Pa. 19104-6030, USA. evhersh@pobox.upenn.edu
authors: Elliot V
authors: EV
authors: Hersh
authors: Sebastian G
authors: SG
authors: Ciancio
authors: Arthur S
authors: AS
authors: Kuperstein
authors: Eric T
authors: ET
authors: Stoopler
authors: Paul A
authors: PA
authors: Moore
authors: Sean G
authors: SG
authors: Boynes
authors: Steven C
authors: SC
authors: Levine
authors: Paul
authors: P
authors: Casamassimo
authors: Rina
authors: R
authors: Leyva
authors: Tanya
authors: T
authors: Mathew
authors: Othman
authors: O
authors: Shibly
authors: Paul
authors: P
authors: Creighton
authors: Gary E
authors: GE
authors: Jeffers
authors: Patricia M A
authors: PM
authors: Corby
authors: Stanley N
authors: SN
authors: Turetzky
authors: Athena
authors: A
authors: Papas
authors: Jillian
authors: J
authors: Wallen
authors: Cynthia
authors: C
authors: Idzik-Starr
authors: Sharon M
authors: SM
authors: Gordon
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage*; D001566:Benzocaine / Q000008:administration & dosage*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010147:Pain Measurement; D017060:Patient Satisfaction; D014677:Pharmaceutical Vehicles; D010919:Placebos; D012646:Self Administration; D013997:Time Factors; D014098:Toothache / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000779:Anesthetics, Local; D005782:Gels; D014677:Pharmaceutical Vehicles; D010919:Placebos; D001566:Benzocaine
keywords: Benzocaine; double stopwatch; methemoglobinemia; pain; toothache; topical anesthetic
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