PMID- 28126226
OWN - NLM
STAT- MEDLINE
DCOM- 20181005
LR  - 20181005
IS  - 1943-4723 (Electronic)
IS  - 0002-8177 (Linking)
VI  - 148
IP  - 3
DP  - 2017 Mar
TI  - Effectiveness and safety of phentolamine mesylate in routine dental care.
PG  - 149-156
LID - S0002-8177(16)30913-8 [pii]
LID - 10.1016/j.adaj.2016.11.017 [doi]
AB  - BACKGROUND: Phentolamine mesylate (PM) is widely used to reverse local anesthesia 
      after dental procedures. Limited knowledge is available regarding effectiveness 
      and safety in routine dental practice. METHODS: The authors conducted 2 national, 
      prospective, noninterventional, postauthorization effectiveness studies (OraVerse 
      Post-Authorization Efficacy Study [ORAPAES] controlled, OraVerse 
      Non-Interventional Study [ORANIS] uncontrolled) in patients receiving a local 
      anesthetic as part of their dental treatment. They investigated time to recovery 
      of normal sensation and function and the frequency of adverse events (AEs). The 
      authors used Kaplan-Meier methods to analyze times to recovery; in ORAPAES, they 
      used hazard ratios based on Cox models using the control group as a reference. 
      RESULTS: In ORAPAES (n = 856), PM reduced the time to recovery of normal 
      sensation and function with a difference in the median time of 70 and 79 minutes, 
      respectively, with similar results observed in ORANIS (n = 445). In ORAPAES, 
      patients in the PM group had, at any time point, a 2.77-fold higher chance of 
      recovery to normal sensation (hazard ratio, 2.77; 95% confidence interval [CI], 
      2.35-3.26; P < .001) and for normal function 2.94-fold higher chance of recovery 
      to normal sensation (95% CI, 2.49-3.47; P < .001) than in the control group. The 
      observed incidence of AEs with PM treatment was 8.4% in ORAPAES (95% CI, 
      6.2-10.9) and 9.7% (95% CI, 7.1-12.7) in ORANIS. No serious AEs occurred. 
      CONCLUSIONS: PM substantially reduced the time to recovery of normal sensation 
      and function after local anesthesia in routine dental treatment. The results 
      confirm the effectiveness, safety, and tolerability of PM used in patients with 
      routine dental conditions in Germany, and that PM augments the safety of dental 
      treatments. PRACTICAL IMPLICATIONS: The authors determined that PM is well suited 
      to reverse local anesthesia after routine dental procedures.
CI  - Copyright (c) 2017 American Dental Association. Published by Elsevier Inc. All 
      rights reserved.
FAU - Daublander, Monika
AU  - Daublander M
FAU - Liebaug, Frank
AU  - Liebaug F
FAU - Niedeggen, Gabriele
AU  - Niedeggen G
FAU - Theobald, Karlheinz
AU  - Theobald K
FAU - Kurzinger, Marie-Laure
AU  - Kurzinger ML
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20170123
PL  - England
TA  - J Am Dent Assoc
JT  - Journal of the American Dental Association (1939)
JID - 7503060
RN  - 0 (Adrenergic alpha-Antagonists)
RN  - 0 (Anesthetics, Local)
RN  - Z468598HBV (Phentolamine)
SB  - IM
MH  - Adolescent
MH  - Adrenergic alpha-Antagonists/*therapeutic use
MH  - Adult
MH  - Anesthesia, Dental/*methods
MH  - Anesthetics, Local/*therapeutic use
MH  - Child
MH  - *Dental Care
MH  - Female
MH  - Germany
MH  - Humans
MH  - Male
MH  - Phentolamine/*therapeutic use
MH  - Prospective Studies
MH  - Recovery of Function
OTO - NOTNLM
OT  - Germany
OT  - Phentolamine mesylate effectiveness
OT  - noninterventional study
OT  - safety
EDAT- 2017/01/28 06:00
MHDA- 2018/10/06 06:00
CRDT- 2017/01/28 06:00
PHST- 2016/09/29 00:00 [received]
PHST- 2016/11/16 00:00 [revised]
PHST- 2016/11/16 00:00 [accepted]
PHST- 2017/01/28 06:00 [pubmed]
PHST- 2018/10/06 06:00 [medline]
PHST- 2017/01/28 06:00 [entrez]
AID - S0002-8177(16)30913-8 [pii]
AID - 10.1016/j.adaj.2016.11.017 [doi]
PST - ppublish
SO  - J Am Dent Assoc. 2017 Mar;148(3):149-156. doi: 10.1016/j.adaj.2016.11.017. Epub 
      2017 Jan 23.