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A pilot double blinded clinical trial to compare between Tramadol HCL and Lidocaine HCL as local anaesthesia amongst hospital-outpatient adult dental attendees Mosul-Iraqi Tahani A. Alsandook, PhD. Dean of College of Dentistry/University of Mosul/Mosul/Iraq. Tahani_Alsandook@yahoo.com Yahya A. Al-Haideri, MSc. Assistant Lecturer in Oral and Maxillofacial Surgery Department /College of Dentistry /University of Mosul/ Mosul/Iraq. Abstract
Aim of the study: The aim of the current study is to compare the local anesthetic action of tramadol HCL (with adrenaline) and lidocaine HCL (with adrenaline) in minor oral surgery. Method: A double blind study including 124 patients, requiring minor oral surgery (conventional tooth extraction, surgical removal of impacted teeth and periapical surgery) in the lower molar teeth, allocated randomly into two groups: Group A (n=62), in which each patient received initial dose of one dental cartridge, 1.8ml, from drug A (36mg of Lidocaine HCL with (0.0225mg) adrenalin), for conventional tooth extraction, doubled in case of surgical removal of impacted tooth and periapical surgery. Group B (n=62) received one dental cartridge, 1.8ml, from drug B (50 mg of tramadol HCL and (0.0225mg) adrenalin diluted to 1.8 ml by distilled water), again this dose was doubled in case of surgical removal of impacted tooth and periapical surgery. For each patient the onset of anesthesia, number of cartridges used, duration of surgery and the degree of pain (with a 10-cm visual analog scale VAS), had been recorded during the operation.Postoperatively, the patients were instructed to record exactly when the parasthesia disappear and any adverse effects such as nausea and or vomiting on the first day of operation. Result: there was no significant difference between the two study groups in the number of cartridges (1.33/±0.510, 1.37/± 0.519)nor the onset of anesthesia(2.95/±1.46, 3.14/±1.31) minutes, intraoperative pain (0.1935/±0.697, 0.2096/±0.656), duration of surgery (12.77/±10.51, 14.11/±11.66) minutes, and side effects. However there was a significant difference in duration of anesthesia(153.14/±35.10, 117.11/±26.88) minutes, where the group A achieved longer duration of action of local anesthesia. Conclusion: These study findings suggested that Tramadol HCL can be used as alternative to Lidocaine HCL in combination with adrenaline to achieve local anesthesia in situation where Lidocaine HCL is contraindicated or when adequate local anesthesia with minimal paraesthesia is required. Validation and replication of these study findings should be considered in future research. Key words: local anesthesia, tramadol, lidocaine, adrenaline, new local anesthesia, analgesia. by the patient, to reduce the amount of pain killer sequential numbers in the order in which Compression was the first method of local intake post operatively i.e. it is ideal if the they were enrolled, and received their anesthesia used in the antiquity. Cold, as anesthesia used have a powerful analgesic local anesthesia, was widely used until activity and relatively for a long period. Indeed, computer-generated 17thCentury (Franco, 2007). The natural the use of Tramadol HCL will be beneficial in schedule prepared before the start of the Cocaine was the first drug used as local patients with certain circumstances e.g., children. anesthetic agent at about the end of Therefore, from this point of view, if, Tramadol Exclusion criteria included history of 18thCentury, unfortunately the serious side compromised medical status, history of effects of this drug made the researchers to posses local anesthetic action equivalent allergy or hypersensitivity to the drugs look for safe drugs (Calvey and Williams, to that of Lidocaine, it will be more superior than used in this trial, pregnant or lactating 2008). In the last century a group of safe lidocaine as it will provide postoperative local anaesthetics have been introduced such as Lidocaine 1948 which is the most Patients were assigned into 2 groups of commonly used local anaesthetics till now, Patients and Methods:
treatment; sample size was 62 subjects per A randomized, double-blind study was bupivacaine 1963 (Rahn and Ball, 2001), conducted at Oral and Maxillofacial Group A: each patient received initial dose however, because no drug is currently Department/College of one dental cartridge, 1.8 ml, from drug A devoid of potential toxicity the search for new better local anesthetics continued May2011 and September 2012. The study (0.0225mg) (New Stetic-Colombia)) for (Yagiela et al, 2004). was approved by the local academic conventional tooth extraction, this dose was Tramadol HCL is a centrally acting committee according to relevant guidelines. doubled in case of surgical removal of opioid(Shipton, 2000), with a relatively low The purposes of the study were explained impacted tooth and periapical surgery. to all patients included in the study and Group B: each patient received initial dose effective for the treatment of moderate to written informed consent was obtained of one dental cartridge, 1.8 ml, from drug B severe pain such as, postsurgical pain, (tramadol HCL 50mg, according to the obstetric pain, terminal cancer pain and recommended dose in BNF 2005, and pain of coronary origin (Scott and Perry, voluntarily and their withdrawal from the epinephrine (0.0225mg)) for conventional 2000).In the last decade few researches study at any time will not affect the tooth extraction, again this dose was prove that tramadol HCL can be used as provisional of their treatment. Inclusion doubled in case of surgical removal of local anesthesia in minor soft tissue criteria were as follows: 18 to 45years of impacted tooth and periapical surgery. procedures (Altunkaya etal, 2003), age, any gender, all patients were to The studied drug in group B was prepared Most patients attend dental clinics suffer from undergo elective minor oral surgical pain. So relief of this pain is the most important procedures in the lower molars, including: Department/College objective of those dentists and it is a critical point conventional tooth extraction, surgical Dentistry/Mosul University, who was not in their success. On the other hand it is preferable, removal of impacted third molar and involved in the surgical procedure . The periapical surgery. Patients were assigned label removed from cartridges of drug A, so
cartridges of both drugs (A and B) had a duration of anesthesia and adverse effects similar appearance, coded and blinded to sample size and (0.0048) is the degree of the investigator and subjects. Data analysis: spss program version (11.5) The same investigator performed all the on Pentium IV computer was used to Intra operative pain: the maximum VAS surgical procedures without having any analyze the obtained data. score(4)was recorded in group (A), while idea about the type of anesthesia to be used. Independent-Samples T-Test was used to the minimum (0) was recorded in 56 cases Block of inferior alveolar nerve was used compare parametric variables (cartridges in group A and in 55 cases in group B. The for local anesthetics administration by number, degree of pain, duration of highest mean(0.2096) was recorded in using disposable dental needle gauge (-27- surgery, duration of anesthesia), Mann- group (B), while lowest mean (0.1935) ), length (-32mm) mounted on dental Whitney U Test was used to compare the presented in group (A). Table (1). syringe. Anesthetizing of long buccal nerve The analysis of the data statistically by was delayed and done after being sure that vomiting).The level of significance was set using Independent-Samples T-Test resulted the block anesthesia was success i.e. after appearance of lip parasthesia. Results:
Sample characteristics: included age and The study conducted on 124 patients of (n=62),m/SD=0.2096/±0.656; 124 is the socioeconomic status of patients and oral moderate socieo-economic status,18-45 sample size and (0.00014) is the degree of health. Intraoperatively: years age, 65 female and 59 male. Each Onset of anesthesia: group involved 25 case of surgical Duration of surgery: the maximum Immediately after injection (considered as removal of mesially impacted lower duration recorded was (55) minutes, which time zero) to the time that the patient feel wisdom and 36 conventional extraction presented in group (B), while the minimum parasthesia on his lip, this time interval any of lower molars and 1 periapical was (4) minutes which recorded in both was recorded to be the onset of inferior surgery at the lower first molar. groups. The highest mean (14.11) minutes alveolar nerve block anesthesia. Intraoperative data: was recorded in group (B) while the lowest Measuring of pain intensity: The first Number of cartridges: the results revealed (12.77) minutes was recorded in group incision and/or gingival separation was that only one patient from each group was (A).Table (1). As a result of statistical required additional injection, the maximum analysis of the data by using Independent- administration of long buccal nerve block, numbers of used cartridges were recorded Samples T-Test, there was no significant this time was selected to achieve optimal in both groups which were (3), the differences in the durations of operations local anesthetic effect. The patient was minimum (1) was recorded in the two among the study groups. instructed to inform the investigator by groups. Table (1). moving or rising his left hand at any time during operation if pain was felt.The degree of pain was evaluated with a 10-cm visual analog scale (VAS) (Sriwatanakul et al, 1983). Before starting the treatment, the investigator explained the VAS to the subjects. The VAS consist of an interval scale ranging from zero, representing no pain or discomfort to 10, representing maximum pain. The mean of the VAS scores during the operation was calculated and recorded by dental chair side assistant. During the surgery, when the VAS exceeded 3 points, additional half cartridge (0.9ml) of the same drug was injected into the surgical site, and the total number of the cartridges used during the operation Duration of the surgery: recorded duration represented the time interval from the incision/or gingival separation to the placement of last stitch/or completion of Independent-Samples T-Test showed no tooth extraction. statistically significant difference between Number of cartridges: the two groups(P = 0.728, f= Independent- ±11.66; 124 is the sample size and The total number of used cartridges were Samples T-Test showed no statistically (0.0036) is the degree of freedom). recorded for each procedure in both significant difference between the two Postoperative data: groups(P = 0.728, f= 0.290; Group Duration of anesthesia: the maximum Postoperatively: duration of anesthesia recorded was (300) Duration of anesthesia: which was the time B(n=62), m/SD=1.37/± 0.519. 124 is the minutes, which presented in group (A), interval between the appearance of lip sample size and (0.0009) is the degree of while the minimum was (90) minutes paresthsia and its disappearance, as which recorded in group (B). The highest reported by the patient. Onset of anesthesia: the fastest onset of mean (153.14) minutes was recorded in Recording of adverse effect: action was recorded in group (A) which group (A) while the lowest (117.38) Nausea and vomiting are common adverse was (0.1) minute and the slowest one effects of tramadol HCL(Cossmann et al., which was (7) minutes recorded in both 1997). Persistent nausea (defined as the groups. The highest mean onset (3.145) recorded in group (B). Table (2). urge to vomit lasting for more than 30 minute was recorded in group (B), while The highest mean (153.14) minutes was minutes) and two or more episodes of the lowest mean onset (2.951) was recorded in group (A) while the lowest vomiting were treated with IV injection of recorded in group (A). Table (1).The (117.38) minutes recorded in group (B). statistical analysis of the assumed data vomiting were recorded using a three point Independent-Samples Statistically Independent-Samples T-Test ordinal scale (0 = none, nausea = 1, and showed significant difference between the vomiting = 2). Patients were reviewed after (p=0.440, F= 0.551; Group A (n=62), 24 hours and information about the m/SD=2.95/±1.46);
The evidence obtained in this study 117.11/±26.88; 124 is the sample size and demonstrates that tramadol HCL exhibits mechanism. In addition it has been (0.249) is the degree of freedom). local anesthetic effect that enables oral reported that there is no competition for a Adverse effects: surgeon to perform pain free minor oral common binding site on the Na-channel Regarding the adverse effects (nausea and surgical procedures when infiltrated to between opioid, meperidine, and the local vomiting) which were recorded in the first susceptible neurons. anesthesia lidocaine (Brau et al, 2000). 24 hours after surgery the study revealed that, there were only two observation of In this study there was no significant nausea in group A, while in group B four difference between tramadol and lidocaine observation of nausea and one of vomiting groups in the, volume of local anesthetic were recorded. Table (3). solution administrated to produce local anesthesia nor the onset of anesthesia, intraoperative pain using VAS, and side effect. However there was a significant difference in duration of anesthesia. Where Lidocaine group achieved longer duration of action of local anesthesia. Yet this effect Future research implications Further studies are required to validate, replicate our findings and to evaluate pharmacokinetics and mechanism of action Conclusion:
Tramadol HCL can be used as alternative to lidocaine HCL in combination with adrenaline to achieve local anesthesia in contraindicated or when adequate local anesthesia with minimal parasthesia is References:
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