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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. [email protected] 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. Introduction:
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 anesthesia used in the antiquity. Cold, as anesthesia used have a powerful analgesic activity and relatively for a long period. Indeed, 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. Therefore, from this point of view, if, Tramadol 18thCentury, unfortunately the serious side 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 such as Lidocaine 1948 which is the most commonly used local anaesthetics till now, Patients and Methods:
treatment; sample size was 62 subjects per Group A: each patient received initial dose of one dental cartridge, 1.8 ml, from drug A devoid of potential toxicity the search for conventional tooth extraction, this dose was committee according to relevant guidelines. opioid(Shipton, 2000), with a relatively low The purposes of the study were explained to all patients included in the study and Group B: each patient received initial dose effective for the treatment of moderate to of one dental cartridge, 1.8 ml, from drug B obstetric pain, terminal cancer pain and pain of coronary origin (Scott and Perry, voluntarily and their withdrawal from the epinephrine (0.0225mg)) for conventional provisional of their treatment. Inclusion criteria were as follows: 18 to 45years of The studied drug in group B was prepared Most patients attend dental clinics suffer from pain. So relief of this pain is the most important procedures in the lower molars, including: objective of those dentists and it is a critical point in their success. On the other hand it is preferable, 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 Data analysis: spss program version (11.5) score(4)was recorded in group (A), while idea about the type of anesthesia to be used. 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 using disposable dental needle gauge (-27- 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 significantdifference(p=0.895,F=.048;Gro Results:
Sample characteristics: included age and socioeconomic status of patients and oral sample size and (0.00014) is the degree of Immediately after injection (considered as duration recorded was (55) minutes, which time zero) to the time that the patient feel presented in group (B), while the minimum parasthesia on his lip, this time interval was recorded to be the onset of inferior groups. The highest mean (14.11) minutes was recorded in group (B) while the lowest Number of cartridges: the results revealed 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 differences in the durations of operations local anesthetic effect. The patient was instructed to inform the investigator by moving or rising his left hand at any time degree of pain was evaluated with a 10-cm visual analog scale (VAS) (Sriwatanakul et al, 1983). Before starting the treatment, the subjects. The VAS consist of an interval scale ranging from zero, representing no scores during the operation was calculated and recorded by dental chair side assistant. 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 placement of last stitch/or completion of (p=0.503,F=0.300;GroupA(n=62),m/SD=1 statistically significant difference between the two groups(P = 0.728, f= Independent- The total number of used cartridges were duration of anesthesia recorded was (300) Duration of anesthesia: which was the time sample size and (0.0009) is the degree of which recorded in group (B). The highest Onset of anesthesia: the fastest onset of effects of tramadol HCL(Cossmann et al., 1997). Persistent nausea (defined as the vomiting were treated with IV injection of statistical analysis of the assumed data vomiting were recorded using a three point 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), groups(p=0.01,F=2.254;GroupA(n=62),m/ 117.11/±26.88; 124 is the sample size and local anesthetic effect that enables oral reported that there is no competition for a Regarding the adverse effects (nausea and between opioid, meperidine, and the local vomiting) which were recorded in the first anesthesia lidocaine (Brau et al, 2000). 24 hours after surgery the study revealed that, there were only two observation of 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 difference in duration of anesthesia. Where Lidocaine group achieved longer duration of action of local anesthesia. Yet this effect Further studies are required to validate, pharmacokinetics and mechanism of action Conclusion:
adrenaline to achieve local anesthesia in References:
Altunkaya H, Ozer Y, Kargi E, Ozkocak I, (2004) The postoperative analgesic effect local anesthetic. AnesthAnalg; 99:1461-4. Statistical analysis of the data by using non To our best of knowledge this is the first study in which tramadol HCL used as local prilocaine for minor surgical procedures , demonstrated that there was no significant comparing its anesthetic effect with that of lidocaine HCL, furthermore, no published The objective of the current study was to Channels in Amphibian Peripheral Nerves . acting opioid, it is clinically effective for the treatment of moderate to severe pain Practice of Pharmacology for Anaesthetists. with a relative low addiction incidence. In produces analgesia against multiple pain similar to that of prilocaine 2% when used McCartney C. (1997): Tolerance and safety intradermally for excision of soft tissue obstetric pain, terminal cancer pain, and of tramadol use: results of international lesions (Altunkaya et al, 2003; Kargi et al, pain of coronary origin, and it has been studies and data from drug surveillance. 2009). Other studies showed that tramadol HCL has a local anesthetic activity similar HCL(Mert et al, 2002; Mert et al, 2006). The current study was correlated with these conduction blocking potency. Clinical and Kargi E., Isıkdemir A., Tokgöz H., Erol B., Isıkdemir F., Hancı V., Payaslı C .(2009): anesthetic effect, but it should be noted that tramadol, have shown that local anesthetic Comparison of Local Anesthetic Effects of effects of opioids typically cannot reversed by pretreatment with naloxone (Tsai et al, studies involved only soft tissue surgery. 2001). The lack of antagonizing ability of Mert T. , Gunes Y., Ozcengiz D., Gunay I., because the effects of tramadol HCL on the nerve conduction are more likely mediated peripheral nerves. Eur J Pharmacol;543:54- dentistry -Articaine and epinephrine for pain. ClinPharmacol Ther;34:234–9. conduction blocks by an opioid and local review of its use in perioperative pain. Natalini G, Rosano A, Franschetti ME, et potentials in rats. Anesth Analg;92:1547- pressure and photoplethysmography during future. Anesth Intensive Care.; 28:363-74. Dentistry. 5th ed.St Louis: Mosby; 2004.

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