Acta Anaesthesiologica Taiwanica 52 (2014) 59e63
Contents lists available at ScienceDirect
Acta Anaesthesiologica Taiwanica journal homepage: www.e-aat.com
Original Article
Comparison of 4% articaine and 0.5% bupivacaine anesthetic efficacy in orthodontic extractions: Prospective, randomized crossover study Ashwin Thakare 1, Kalyani Bhate 1, Rahul Kathariya 2 * 1 2
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 18, India Department of Periodontology and Oral Implantology, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 18, India
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 March 2013 Received in revised form 19 February 2014 Accepted 24 February 2014
Aim: Articaine and bupivacaine are both amide-type local anesthetic (LA) agents, of almost equal potency. However, lidocaine is considered the gold standard and is the most widely used anesthetic agent because of its potency, safety, and efficiency. Articaine is fast acting and bupivacaine is a long-lasting LA. The aim of this randomized controlled crossover clinical study was to evaluate and compare the clinical anesthetic efficacy of 4% articaine and 0.5% bupivacaine in orthodontic extractions models. Methods: Forty systemically healthy patients (age range: 10e18 years), requiring premolar extraction for orthodontic reasons (all 4 premolars) were included. Patients were categorized into two groups (4% articaine and 0.5% bupivacaine) in a crossover manner (160 premolars). Parameters recorded included: time of anesthetic onset, duration of postoperative analgesia, time to first rescue analgesic medication, and visual analog scale (VAS). At the first appointment, both upper and lower premolars were extracted on one side of the jaws (right or left). A fixed volume of 1.4 mL of 4% articaine or 0.5% bupivacaine (based on a computer-generated list) was infiltrated in the buccal vestibule (local infiltration) for extraction. At the second appointment, after a washout period of 15 days, the anesthetic agent that was not administered at the first appointment was administered in a crossover manner. Each patient was evaluated using a 100-mm VAS during and after extraction. Results: The results showed that 4% articaine had significantly faster onset of action and lower VAS scores when compared with bupivacaine. However, the duration of analgesia and time to first rescue analgesic medication was longer in the bupivacaine group. Conclusion: Articaine seemed to have better potency and efficacy in terms of onset of action and lower pain scores compared to the bupivacaine group. Further studies are required to confirm these results. Copyright © 2014, Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. All rights reserved.
Key words: bupivacaine; carticaine; pain measurement; visual analog pain scale; tooth extraction
1. Introduction Local anesthesia and pain management are the most important tenets in any oral surgical procedure. Patient compliance and effective surgical procedure mandates complete pain control in order to gain patient cooperation and manage patient anxiety. Pain perception depends upon the patient's pain threshold and quality of local anesthetics (LAs) used. LAs are believed to be the most frequently used drugs in clinical dentistry. It has been estimated
Conflicts of interest: There is no financial relationship between any author and any commercial organizations, which may pose a conflict of interest. * Corresponding author. Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y Patil Vidyapeeth, Santtukaram Nagar, Pune 411018, India. E-mail address: [email protected] (R. Kathariya).
that >300 million cartridges of LA are administered annually by dentists in the United States.1 LAs are chemicals that block nerve conduction in a specific, temporary, and reversible manner, without affecting the patient's consciousness. The molecule consists of two poles: a hydrophilic tertiary or secondary amino group, and a lipophilic aromatic ring. According to the type of intermediate alkyl linkage between them, they are classified under ester-type anesthetics, with an aminoester bond and whose prototype is procaine, and the amide-type with an amino-amide bond and whose prototype is lidocaine.2 Various LA agents have been studied and reported in the literature, but, because of the long latency period of procaine and allergies to ester anesthetics, lidocaine after its synthesis in 1943 by €fgren quickly became the gold standard because of its minNils Lo imal side effects and effective pain control.3 Articaine and bupivacaine are effective and comparable to lidocaine. Articaine (Fig. 1) is
http://dx.doi.org/10.1016/j.aat.2014.04.006 1875-4597/Copyright © 2014, Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. All rights reserved.
60
A. Thakare et al.
crossover manner (Fig. 3) on the other side of the face. The parameters were again recorded in a similar manner. A previously calibrated examiner (A.T.) performed all the clinical assessments to ensure adequate intra-examiner reproducibility. The examiner was considered calibrated once a statistically significant correlation and statistically nonsignificant difference between duplicate measurements were obtained (r ¼ 0.87 for time of onset; r ¼ 0.90 for duration of postoperative analgesia, r ¼ 0.93 for time of first rescue analgesic medication, and r ¼ 0.81 for VAS score). Fig. 1. Chemical structure and formula of articaine (RS)-methyl 4-methyl-3-(2-propylaminopropanoylamino) thiophene-2-carboxylate.
a safe anesthetic with a fast onset and an adequate duration with few side effects4 (Table 1). Bupivacaine (Fig. 2) is often chosen for prolonged postoperative pain control and analgesia in extended operations5,6 (Table 1). Moreover, some authors have attributed its ability to attain longer postoperative analgesic periods, reducing analgesic requirements in the early postoperative hours when the maximum pain intensity is reached.7,8 However, it has certain side effects with a low therapeutic index. This split-mouth design reduces possible research bias by avoiding physiological and psychological differences between tested individuals.9 For orthodontic extractions, both anesthetics can be compared in the same patient, because most orthodontic extractions are bilateral, in the same anatomical positions. They present almost equal difficulty in removal, thereby requiring the same armamentarium, technique, and duration. This makes the comparison between articaine and bupivacaine in the same patient, in two different appointments justified and unbiased. Numerous studies have been reported in the literature comparing articaine and lidocaine. However, the dearth of studies comparing articaine and bupivacaine makes this study reasonable. The aim of our study was to assess the clinical efficacy of 4% articaine and 0.5% bupivacaine in an orthodontic extraction model in symmetrically positioned maxillary and mandibular premolars.
2. Materials and methods This prospective, randomized crossover study was carried out from January 2011 to September 2011. The study population consisted of 40 age- and sex-balanced (age range 10e18 years) systemically healthy individuals, attending the Outpatient Section, Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College and Hospital, Pune, India. Written informed consent was obtained from those who agreed to participate voluntarily. Ethical clearances were obtained from the Ethical Committee and Review Boards of the institution. Systemically healthy individuals, without reported allergy to LAs, requiring extraction of their premolars for orthodontic reasons, were included. Study parameters included time of anesthetic onset, duration of postoperative analgesia, time to first rescue analgesic medication, and visual analog scale (VAS) score. All extractions were done at 9:00 AM. VAS score was recorded intraoperatively 5 minutes after injection, postoperatively every 2 hours at 11.30 AM, 1.30 PM, 3.30 PM, 5.30 PM, 7.30 PM, and 9.30 PM. A computer-generated list was used to allocate each patient into either 4% articaine or 0.5% bupivacaine groups. At the first appointment, a fixed volume of 1.4 mL 4% articaine or 0.5% bupivacaine was infiltrated in the buccal vestibule of maxillary and mandibular premolars (one side of the face). After attaining adequate anesthesia, the extraction procedure was carried out under aseptic conditions. At the second appointment after a washout period of 15 days, the same procedure was repeated in a
2.1. Statistical analysis Student's t test was used to compare qualitative means. A p value
Contents lists available at ScienceDirect
Acta Anaesthesiologica Taiwanica journal homepage: www.e-aat.com
Original Article
Comparison of 4% articaine and 0.5% bupivacaine anesthetic efficacy in orthodontic extractions: Prospective, randomized crossover study Ashwin Thakare 1, Kalyani Bhate 1, Rahul Kathariya 2 * 1 2
Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 18, India Department of Periodontology and Oral Implantology, Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune 18, India
a r t i c l e i n f o
a b s t r a c t
Article history: Received 27 March 2013 Received in revised form 19 February 2014 Accepted 24 February 2014
Aim: Articaine and bupivacaine are both amide-type local anesthetic (LA) agents, of almost equal potency. However, lidocaine is considered the gold standard and is the most widely used anesthetic agent because of its potency, safety, and efficiency. Articaine is fast acting and bupivacaine is a long-lasting LA. The aim of this randomized controlled crossover clinical study was to evaluate and compare the clinical anesthetic efficacy of 4% articaine and 0.5% bupivacaine in orthodontic extractions models. Methods: Forty systemically healthy patients (age range: 10e18 years), requiring premolar extraction for orthodontic reasons (all 4 premolars) were included. Patients were categorized into two groups (4% articaine and 0.5% bupivacaine) in a crossover manner (160 premolars). Parameters recorded included: time of anesthetic onset, duration of postoperative analgesia, time to first rescue analgesic medication, and visual analog scale (VAS). At the first appointment, both upper and lower premolars were extracted on one side of the jaws (right or left). A fixed volume of 1.4 mL of 4% articaine or 0.5% bupivacaine (based on a computer-generated list) was infiltrated in the buccal vestibule (local infiltration) for extraction. At the second appointment, after a washout period of 15 days, the anesthetic agent that was not administered at the first appointment was administered in a crossover manner. Each patient was evaluated using a 100-mm VAS during and after extraction. Results: The results showed that 4% articaine had significantly faster onset of action and lower VAS scores when compared with bupivacaine. However, the duration of analgesia and time to first rescue analgesic medication was longer in the bupivacaine group. Conclusion: Articaine seemed to have better potency and efficacy in terms of onset of action and lower pain scores compared to the bupivacaine group. Further studies are required to confirm these results. Copyright © 2014, Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. All rights reserved.
Key words: bupivacaine; carticaine; pain measurement; visual analog pain scale; tooth extraction
1. Introduction Local anesthesia and pain management are the most important tenets in any oral surgical procedure. Patient compliance and effective surgical procedure mandates complete pain control in order to gain patient cooperation and manage patient anxiety. Pain perception depends upon the patient's pain threshold and quality of local anesthetics (LAs) used. LAs are believed to be the most frequently used drugs in clinical dentistry. It has been estimated
Conflicts of interest: There is no financial relationship between any author and any commercial organizations, which may pose a conflict of interest. * Corresponding author. Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y Patil Vidyapeeth, Santtukaram Nagar, Pune 411018, India. E-mail address: [email protected] (R. Kathariya).
that >300 million cartridges of LA are administered annually by dentists in the United States.1 LAs are chemicals that block nerve conduction in a specific, temporary, and reversible manner, without affecting the patient's consciousness. The molecule consists of two poles: a hydrophilic tertiary or secondary amino group, and a lipophilic aromatic ring. According to the type of intermediate alkyl linkage between them, they are classified under ester-type anesthetics, with an aminoester bond and whose prototype is procaine, and the amide-type with an amino-amide bond and whose prototype is lidocaine.2 Various LA agents have been studied and reported in the literature, but, because of the long latency period of procaine and allergies to ester anesthetics, lidocaine after its synthesis in 1943 by €fgren quickly became the gold standard because of its minNils Lo imal side effects and effective pain control.3 Articaine and bupivacaine are effective and comparable to lidocaine. Articaine (Fig. 1) is
http://dx.doi.org/10.1016/j.aat.2014.04.006 1875-4597/Copyright © 2014, Taiwan Society of Anesthesiologists. Published by Elsevier Taiwan LLC. All rights reserved.
60
A. Thakare et al.
crossover manner (Fig. 3) on the other side of the face. The parameters were again recorded in a similar manner. A previously calibrated examiner (A.T.) performed all the clinical assessments to ensure adequate intra-examiner reproducibility. The examiner was considered calibrated once a statistically significant correlation and statistically nonsignificant difference between duplicate measurements were obtained (r ¼ 0.87 for time of onset; r ¼ 0.90 for duration of postoperative analgesia, r ¼ 0.93 for time of first rescue analgesic medication, and r ¼ 0.81 for VAS score). Fig. 1. Chemical structure and formula of articaine (RS)-methyl 4-methyl-3-(2-propylaminopropanoylamino) thiophene-2-carboxylate.
a safe anesthetic with a fast onset and an adequate duration with few side effects4 (Table 1). Bupivacaine (Fig. 2) is often chosen for prolonged postoperative pain control and analgesia in extended operations5,6 (Table 1). Moreover, some authors have attributed its ability to attain longer postoperative analgesic periods, reducing analgesic requirements in the early postoperative hours when the maximum pain intensity is reached.7,8 However, it has certain side effects with a low therapeutic index. This split-mouth design reduces possible research bias by avoiding physiological and psychological differences between tested individuals.9 For orthodontic extractions, both anesthetics can be compared in the same patient, because most orthodontic extractions are bilateral, in the same anatomical positions. They present almost equal difficulty in removal, thereby requiring the same armamentarium, technique, and duration. This makes the comparison between articaine and bupivacaine in the same patient, in two different appointments justified and unbiased. Numerous studies have been reported in the literature comparing articaine and lidocaine. However, the dearth of studies comparing articaine and bupivacaine makes this study reasonable. The aim of our study was to assess the clinical efficacy of 4% articaine and 0.5% bupivacaine in an orthodontic extraction model in symmetrically positioned maxillary and mandibular premolars.
2. Materials and methods This prospective, randomized crossover study was carried out from January 2011 to September 2011. The study population consisted of 40 age- and sex-balanced (age range 10e18 years) systemically healthy individuals, attending the Outpatient Section, Department of Oral and Maxillofacial Surgery, Dr. D.Y. Patil Dental College and Hospital, Pune, India. Written informed consent was obtained from those who agreed to participate voluntarily. Ethical clearances were obtained from the Ethical Committee and Review Boards of the institution. Systemically healthy individuals, without reported allergy to LAs, requiring extraction of their premolars for orthodontic reasons, were included. Study parameters included time of anesthetic onset, duration of postoperative analgesia, time to first rescue analgesic medication, and visual analog scale (VAS) score. All extractions were done at 9:00 AM. VAS score was recorded intraoperatively 5 minutes after injection, postoperatively every 2 hours at 11.30 AM, 1.30 PM, 3.30 PM, 5.30 PM, 7.30 PM, and 9.30 PM. A computer-generated list was used to allocate each patient into either 4% articaine or 0.5% bupivacaine groups. At the first appointment, a fixed volume of 1.4 mL 4% articaine or 0.5% bupivacaine was infiltrated in the buccal vestibule of maxillary and mandibular premolars (one side of the face). After attaining adequate anesthesia, the extraction procedure was carried out under aseptic conditions. At the second appointment after a washout period of 15 days, the same procedure was repeated in a
2.1. Statistical analysis Student's t test was used to compare qualitative means. A p value
