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Articaine hydrochloride is a safe and effective local anesthetic
A RT I C L E A N A LY S I S & E VA LUAT I O N Articaine hydrochloride is a safe and effective local anesthetic
Original Article:
Malamed SF, Gagnon S, Leblanc D. Articaine hydrochloride: a study of the safety of a new amide local anesthetic. J Am Dent Assoc 2001;132:177-85.
• Level of Evidence: • Purpose:
1
• Source of Funding:
Materials and funding from Spécialités Septodont, the manufacturer of the drug products used in the 3 trials
• Type of Study/Design:
Report on 3 identical single-dose, randomized, double-blind, parallel group, active-controlled multicenter studies
To present the results of a 3-study clinical program designed to compare the safety of 4% articaine and 1:100,000 epinephrine with that of 2% lidocaine and 1:100,000 epinephrine
S U M M A RY SUBJECTS Evaluated were 1325 patients (882 in the articaine group, 443 in the lidocaine group) aged 4 to 80 years undergoing either simple or complex general dental procedures. Mean ages were 36.2 years in the articaine group and 36.5 years in the lidocaine group. Exclusion criteria included pregnancy, allergy or sensitivity to sulfites or amide-type local anesthetics, cardiac or neurologic disease, history of paroxysmal tachycardia, severe untreated hypertension or bronchial asthma, soft tissue infection at the site of injection, intake of analgesics within 24 hours before admin-
istration of the anesthetic, and bony, fully impacted teeth or maxillofacial surgery.
EXPOSURE A maximum dose of 7.0 mg of 4% articaine or 2% lidocaine per kilogram of body weight was administered as submucosal infiltration or nerve block. Subjects were administered enough anesthetic to achieve adequate anesthesia. MAIN OUTCOME MEASURE Reports of adverse events at 24 hours and at 7 days after the local anesthetic and subsequent dental procedure was performed.
MAIN RESULTS The overall incidence of adverse events in the combined studies was 22% in the articaine group and 20% in the lidocaine group. Only 4% in each group, however, had adverse events considered by the investigator to be related to the respective study medications. The most frequently reported drugrelated adverse events in the articaine group were paresthesia (.9%), hypesthesia (.7%), headache (.55%), infection (.45%), and pain (.3%). Similar numbers of adverse events were reported in the lidocaine group.
J Evid Base Dent Pract 2001;1:119-20 Copyright © 2001 by Mosby, Inc doi:10.1067/med.2001.118970
119
Table 3. Adverse events reported by 1% or more of patients in either treatment group* Treatment group (n [%]) Body system/ adverse event Body as a whole Face edema Headache Infection Pain Oral system Gingivitis Nervous system Hypesthesia Paresthesia
Articaine 4% with epinephrine 1:100,000 (n = 882)
Lidocaine 2% with epinephrine 1:100,000 (n = 443)
13 (1) 31 (4) 10 (1) 114 (13)
6 (1) 15 (3) 3 (<1) 54 (12)
13 (1)
5 (1)
7 (<1) 11 (1)
5 (1) 2 (<1)
*Report of all adverse events, regardless of whether they were drug-related. (Reprinted from Malamed SF, Gagnon S, LeBlanc D. J Am Dent Assoc 2001;132:17785. Copyright © 2001 American Dental Association. Reprinted by permission of ADA Publishing, a Division of ADA Business Enterprises, Inc.)
C O M M E N TA RY CONCLUSIONS Four percent articaine with 1:100,000 epinephrine provides effective anesthesia with a low risk of toxicity in both adults and children. The efficacy of articaine was reported in a previous article: Malamed SF, Gagnon S, LeBlanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc 2000;131(5):635-42.
ANALYSIS In this study, the authors present the findings of 3 identical single-dose, randomized, doubleblind, parallel-group, active-controlled multicenter (27 sites in Great Britain and the United States) studies in which the safety and efficacy of 4% articaine with 1:100,000 epinephrine was compared with 2% lidocaine with 1:100,000 epinephrine. The subjects in the study were stratified according to the complexity of their dental • Content Reviewer: • Biostatistical/Epidemiology Reviewer: • Editor:
120 Malamed et al
procedure and randomized in a 2:1 ratio (increasing the number of subjects in the articaine group) to receive either articaine or lidocaine as their local anesthetic. The subjects were then contacted twice by telephone, 24 hours and 7 days after the procedure, and asked if they had experienced any adverse events. The adverse events reported were then categorized as postprocedural or drug-related. The conclusions drawn in the study are based on well-controlled, doubleblind, randomized clinical trials conducted at multiple sites. Because the study used a telephone interview, the results may be questioned because they are based on the subjective answers of the subjects—not on an objective examination and diagnosis by the researcher. This concern is raised by the authors, and the methodology used is standard protocol for this type of study design.
Jeffrey W. Hutter, DMD, MEd, Boston University School of Dental Medicine, Boston, Mass Philippe Hujoel, MSD, PhD, University of Washington, Seattle Michael Newman, DDS, UCLA School of Dentistry, Los Angeles, Calif
Journal of Evidence-Based Dental Practice
October 2001
Original Article:
Malamed SF, Gagnon S, Leblanc D. Articaine hydrochloride: a study of the safety of a new amide local anesthetic. J Am Dent Assoc 2001;132:177-85.
• Level of Evidence: • Purpose:
1
• Source of Funding:
Materials and funding from Spécialités Septodont, the manufacturer of the drug products used in the 3 trials
• Type of Study/Design:
Report on 3 identical single-dose, randomized, double-blind, parallel group, active-controlled multicenter studies
To present the results of a 3-study clinical program designed to compare the safety of 4% articaine and 1:100,000 epinephrine with that of 2% lidocaine and 1:100,000 epinephrine
S U M M A RY SUBJECTS Evaluated were 1325 patients (882 in the articaine group, 443 in the lidocaine group) aged 4 to 80 years undergoing either simple or complex general dental procedures. Mean ages were 36.2 years in the articaine group and 36.5 years in the lidocaine group. Exclusion criteria included pregnancy, allergy or sensitivity to sulfites or amide-type local anesthetics, cardiac or neurologic disease, history of paroxysmal tachycardia, severe untreated hypertension or bronchial asthma, soft tissue infection at the site of injection, intake of analgesics within 24 hours before admin-
istration of the anesthetic, and bony, fully impacted teeth or maxillofacial surgery.
EXPOSURE A maximum dose of 7.0 mg of 4% articaine or 2% lidocaine per kilogram of body weight was administered as submucosal infiltration or nerve block. Subjects were administered enough anesthetic to achieve adequate anesthesia. MAIN OUTCOME MEASURE Reports of adverse events at 24 hours and at 7 days after the local anesthetic and subsequent dental procedure was performed.
MAIN RESULTS The overall incidence of adverse events in the combined studies was 22% in the articaine group and 20% in the lidocaine group. Only 4% in each group, however, had adverse events considered by the investigator to be related to the respective study medications. The most frequently reported drugrelated adverse events in the articaine group were paresthesia (.9%), hypesthesia (.7%), headache (.55%), infection (.45%), and pain (.3%). Similar numbers of adverse events were reported in the lidocaine group.
J Evid Base Dent Pract 2001;1:119-20 Copyright © 2001 by Mosby, Inc doi:10.1067/med.2001.118970
119
Table 3. Adverse events reported by 1% or more of patients in either treatment group* Treatment group (n [%]) Body system/ adverse event Body as a whole Face edema Headache Infection Pain Oral system Gingivitis Nervous system Hypesthesia Paresthesia
Articaine 4% with epinephrine 1:100,000 (n = 882)
Lidocaine 2% with epinephrine 1:100,000 (n = 443)
13 (1) 31 (4) 10 (1) 114 (13)
6 (1) 15 (3) 3 (<1) 54 (12)
13 (1)
5 (1)
7 (<1) 11 (1)
5 (1) 2 (<1)
*Report of all adverse events, regardless of whether they were drug-related. (Reprinted from Malamed SF, Gagnon S, LeBlanc D. J Am Dent Assoc 2001;132:17785. Copyright © 2001 American Dental Association. Reprinted by permission of ADA Publishing, a Division of ADA Business Enterprises, Inc.)
C O M M E N TA RY CONCLUSIONS Four percent articaine with 1:100,000 epinephrine provides effective anesthesia with a low risk of toxicity in both adults and children. The efficacy of articaine was reported in a previous article: Malamed SF, Gagnon S, LeBlanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc 2000;131(5):635-42.
ANALYSIS In this study, the authors present the findings of 3 identical single-dose, randomized, doubleblind, parallel-group, active-controlled multicenter (27 sites in Great Britain and the United States) studies in which the safety and efficacy of 4% articaine with 1:100,000 epinephrine was compared with 2% lidocaine with 1:100,000 epinephrine. The subjects in the study were stratified according to the complexity of their dental • Content Reviewer: • Biostatistical/Epidemiology Reviewer: • Editor:
120 Malamed et al
procedure and randomized in a 2:1 ratio (increasing the number of subjects in the articaine group) to receive either articaine or lidocaine as their local anesthetic. The subjects were then contacted twice by telephone, 24 hours and 7 days after the procedure, and asked if they had experienced any adverse events. The adverse events reported were then categorized as postprocedural or drug-related. The conclusions drawn in the study are based on well-controlled, doubleblind, randomized clinical trials conducted at multiple sites. Because the study used a telephone interview, the results may be questioned because they are based on the subjective answers of the subjects—not on an objective examination and diagnosis by the researcher. This concern is raised by the authors, and the methodology used is standard protocol for this type of study design.
Jeffrey W. Hutter, DMD, MEd, Boston University School of Dental Medicine, Boston, Mass Philippe Hujoel, MSD, PhD, University of Washington, Seattle Michael Newman, DDS, UCLA School of Dentistry, Los Angeles, Calif
Journal of Evidence-Based Dental Practice
October 2001