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Journal of College of Medical Sciences-Nepal, 2010, V Comparative study of tramadol and ketorolac in the pain management of third
molar tooth extraction
M.M. Shaik1, J. Kumar2, S. Mobina3, N. Satyanarayana4, P. Sunitha5 1Lecturer in pharmacology, 2Assistant Professor in Pharmacology, 4Lecturer in Anatomy, 5Lecturer in Physiology, College of Medical Sciences, Bharatpur, Nepal 3Junior Resident, St Joseph’s Dental College, Eluru, Andhra Pradesh, India Abstract
Objective: Clinical comparison of efficacy, duration of action, onset of action, side effects of two most
commonly used analgesics tramadol and ketorolac after the third molar tooth extraction.
Materials and methods: The present study was carried out at department of oral surgery, Mamata Dental
Hospital, Khammam, India. 150 patients were randomly selected and divided into two groups. Group A
received 50 mg of tramadol orally and Group B received 10 mg of ketorolac orally. In both groups dose
was repeated for next 24 hrs. Visual scale analog was used for the collection of pain intensity from the
patients.
Results: In Group A, the analgesia started within 1hour and at the end of 24 hours, pain intensity was
2.12 out of 10 on visual analog scale. In Group B, analgesia started within 30 mins and at the end of 24
hours, the pain intensity was 2.98 on visual analog scale. Sedation associated with dizziness and muscle
relaxation was observed with tramadol in 5% of patients and sweating in 8% patients. While in case of
ketorolac, 33% of patients suffered with side effects. Among them 33% patients suffered with bleeding at
the site of tooth extraction and 20% patients suffered with epigastric pain. The analgesic effect of 50 mg
tramadol lasted up to 6 hours and that of ketorolac lasted for 5 hour.
Conclusion: The study shows that tramadol is a suitable and safe analgesic for the relief of post-extraction
pain and is more effective than ketorolac with prolonged analgesia and minimal side effects.
Key Words: Tramadol, ketorolac, third molar tooth extraction,
Introduction
in the mouth to accommodate the erupting wisdom The wisdom tooth (or third molar) is usually the teeth and therefore, they might not always come into last tooth to erupt into the mouth anytime after about the mouth normally. Wisdom teeth are usually either 16 years of age. Frequently, there is not enough room impacted forwards into the tooth in front or backwards Correspondences: Munvar Miya Shaik into the jaw bone. An impacted wisdom tooth causes infection in the gum surrounding the tooth leading to Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1 pain and swelling. Sometimes cysts also formed due Ketorolac is the inhibition of prostaglandin synthesis to impacted wisdom tooth. To avoid these problems it by competitive blocking of the enzyme cyclooxygenase is always better to remove the tooth. however, the management of pain consequent to tooth extraction is The present study was conducted keeping in view always a major concern for the individual.1, 2 giving the quicker, prolonged and safer post-extraction The way pain is experienced is a reflection of the analgesic after third molar tooth extraction for quicker individual’s emotional, motivational, cognitive, social, recovery of the patient from the post-extraction pain.
and cultural circumstances. The pain of tooth extraction This study was the clinical comparison of efficacy, safety is likely to be the most severe pain that an individual and patient satisfaction of clinically widely used experiences during his or her life.3 Many individuals analgesics, tramadol and ketorolac. There were some rate the pain of tooth extraction as very severe or reports published the comparing the parenteral intolerable. The pain of tooth extraction varies among tramadol and ketorolac in maxiofacilary surgery.8,9 individuals, and each extraction of an individual maybe quite different. Management of post-extraction pain Materials and methods
relieves suffering and leads to earlier mobilization, One hundread and fifty patients from routine shortened hospital stay, reduced hospital costs and admissions with tooth extraction were selected randomly during the period of 10 months from July Tramadol is an atypical centrally-acting analgesic 2008 to April 2009 in the department of oral surgery, because of its combined effects as an opioid agonist Mamata Dental Hospital affiliated to Mamata Dental and a serotonin and noradrenaline reuptake inhibitor.
College, Khammam, India. The inclusion criteria were: The risk of respiratory depression is significantly lower age in between 18 to 60, undergoing into third molar at equianalgesic doses and does not depress the tooth extraction, alertness and stability. The exclusion hypoxic ventilatory response. It has limited effects on criteria were: history of drug or substance abuse, allergy gastrointestinal motor function. Nausea and vomiting to opioids or any other contraindication for the use of are the most common side effects and tramadol does opioids, end stage renal disease, history of seizure or not increase seizure incidence when compared to other any abnormal laboratory tests that could interfere with analgesic agents. Tramadol has been used clinically and evaluated during the past 20 years with broad The methodology and procedure of study had indications leading to its widespread use.7 been cleared by the ethical committee and clinical Ketorolac tromethamine is a member of the research review committee, Mamata Dental College.
pyrrolo-pyrrole group of nonsteroidal anti- All the individuals were well informed about the study, inflammatory drugs (NSAIDs) which was previously methodology and also about the visual analog scale reported for the short term management of moderate prior to tooth extraction. The individuals were to severe pain. The primary molecular basis for anti- unawared of the analgesic which they had taken during inflammatory, antipyretic and analgesic effects of the study. The drugs ketorolac and tramadol were M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction procured from the hospital pharmacy and they have The analgesic effect for group ‘B’ who were taken been assigned a code. Patients were randomly assigned ketorolac started within 30 mins and showed its’s in either treatment groups with an assigned code.
maximum analgesic effect in 1st hour itself. The pain The patients were divided into two groups intensity scored on visual analog is 2.45 at 1st hour.
containing 75 patients in each group. All the codes of But the effect was not sustained till the next dose. The administered drugs were disclosed only after the pain patients felt the pain in the 5th hour itself. The patients assessment. The group ‘A’ received tramadol 50mg scored ‘6.94’ in 5th hour and ‘7.34’ in 6th hour on oral dose before the extraction and dose repeated after visual analog scale. After the second dose, the pain 6 hours. The group ‘B’ received ketorolac 10mg oral intensity was observed for every 6 hrs. At the end of dose before the extraction and dose was repeated after 24 hours, the patient scored ‘2.98’ on visual analog 6hrs. Pain assessment was done by verbal rating using scale. The ‘p’ values were less than 0.05 and were Visual Analog Scale.10, 11 [0 – no pain, 2 - mild pain,
considered statistically significant (Table 1).
4 - tolerable, 6 – distressful pain, 8 – severe pain
According the observations, the analgesic effect and 10 – totally disabling pain]. The pain
is reached quickly in group ‘B’ who received ketorolac.
assessment was started after the tooth extraction at However, the duration of analgesia is more in group time points of 30 min, 1, 2, 3, 4, 5, 6, 12, 18 and 24 ‘A’ patients who received tramadol (Figure 1). Many hrs. The patient’s vital signs including heart rate, patients in group who received ketorolac complained respiratory rate and blood pressure were recorded at of pain before the dosing schedule time i.e. 6 hours.
every time point after the assessment of pain intensity.
The adverse effects in group ‘A’ who took Statistical analyses were performed using Chi-square tramadol were minimum and they were shown only in 8% of the patients. Major adverse effects seen in thisgroup are sweating (8%), sedation (5%) and decrease in blood pressure (4%). But in group ‘B’ who were on The majority of the patients scored an average ketorolac, adverse effects were observed in 33% pain intensity of ‘8.07’ on visual analog scale as the patients. 33% patients reported the bleeding at the maximum pain felt by them in their life time. The extraction site and 20% patients reported the epigastric analgesic effect for group ‘A’ who were taken tramadol pain. The intensity of adverse effects here increased started within 1st hour and reached the maximum as dose increased. With the first dose of ketorolac, analgesic effect in 3 hours. The average rating of pain only 8% patients reported both epigastric pain and the intensity is ‘1.12’ on visual analog scale for the bleeding at the extraction site. (Table 2) maximum analgesic effect felt at 3rd hour and with thefirst dose the analgesic effect sustained for 6 hours.
Discussion
The analgesic effect of tramadol has been increased Inspite of the spectacular advances in modern for every six hours and at the end of the 24 hours, the medicine, no single drug satisfied all the criteria of an patients scored the pain intensity of ‘2.12’ on visual ideal post extraction analgesic. Post extraction analgesia can increase the patients comfort, decrease Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1 the pain and stress after tooth extraction. The present References
study was designed to assess and compare the efficacy, Oladimeji A Akadiri, Ambrose E Obiechina.: safety and the patient satisfaction of two most Assessment of difficulty in third molar surgery-a commonly clinically used analgesics tramadol and systematic review. Oral Maxillofac Surg. 2009 (Apr); ketorolac. Tramadol is a newer opioid with better analgesic action without the risk of developement of Capuzzi P ontebugnoli L M Vaccaro M A.: Extraction tolerance and physical dependence. Now it has been of impacted third molars. A longitudinal prospective using very commonly for chronic pain. From theliterature it has been considered as safest postoperative study on factors that affect postoperative recovery. analgesic. 5, 12 Ketorolac is a most commonly used Oral Surg Oral Med Oral Pathol. 1994 (Apr).; 77 (4) : NSAID for the short term management of pain. Main focus was on the study of pain intensity and the adverse HUSSAIN AL-KHATEEB Taiseer; ALNAHAR Amir.: effects of both the commonly used analgesics, tramadol Pain Experience After Simple Tooth Extraction, Journal and ketorolac. Safety of therapy was based on the of oral and maxillofacial surgery. 2008 (May).; (66), frequency of side effects and evolution of vital signs recorded during the study. From the current study it De Beer Jde V, Winemaker MJ, Donnelly GA, et al.: has been proved that both the drugs are giving betteranalgesic effect. Ketorolac is showing its analgesic Efficacy and safety of controlled-release oxycodone effect very rapidly but the action sustained only up to and standard therapies for postoperative pain after 4 hours (Figure 1). Where as tramadol’s analgesic knee or hip replacement. Can J Surg. 2005; 48:277. effect started after 1 hour and sustained for the longer Recart A, Duchene D, White PF, et al.: Efficacyand safety time i.e. more than 6 hours (Figure 1). The patients of fast-track recovery strategy for patients undergoing who received ketorolac also reported severe adverse laparoscopic nephrectomy. J Endourol 2005; 19:1165. effects like epigastric pain, bleeding at the tooth Watcha MF, Issioui T, Klein KW, et al.: Costs and effect extraction site, nausea and sweating. Tramadol had a of rofecoxib, celecoxib, and otolaryngologic surgery. bit marked effect on blood pressure and also causedsweating in few patients (Figure 2(a), 2(b), 2(c), 2(d).
Pozos-Guillén Ade J, Martínez-Rider R, Aguirre- Conclusion
Bañuelos P, et al.: Analgesic efficacy of tramadol by The overall study profile proved that tramadol is a route of administration in a clinical model of pain. suitable and safe analgesic with longer duration of Proc West Pharmacol Soc. 2005; 48: 61-4. action and less adverse effects for relief of post-extraction pain after third molar extraction and is more Zackova M, Taddei S, Calò P, et al.: Ketorolac vs effective than ketorolac with a long sustained analgesic tramadol in the treatment of postoperative pain during action. The percentage of side effects was minimal.
maxillofacial surgery. Minerva Anestesiol. 2001 M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction Ong KS, Tan JM.:Preoperative intravenous tramadol 11. Seymour RA.:The use of pain scales in assessing the versus ketorolac for preventing postoperative pain efficacy of analgesics in post-operative dental pain after third molar surgery. Int J Oral Maxillofac Eur J Clin Pharmacol. 1982;23(5):441-4. 12. Stamer Um, Maier C, Grond S, Veh-Schmidt, Klaschik 10. Melzack R.:The Mc Gill Pain Questionnaire: Major E, Lehman KA.: Tramadol in the management of post- properties and scoring methods. 1975;277 – 99 operative pain: a double-blind, placebo-and active drug-controlled study. Eur J Ana. 1997;12(6):646-54. Table 1: Comparison of Pain intensities of Tramadol and Penatazocine
Tramadol Ketorolac
Time intervals at which
Pain intensity is measured
Mean ± SD
Mean ± SD
1st Dose
2nd Dose
3rd Dose
4th Dose
Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1 Figure 1: Graphical representation – Comparison of pain intensities of Tramadol and Ketorolac
M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction Table 2: Side effects distribution of Tramadol and Pentazocine
Tramadol Ketorolac
Adverse Effects
No of patients Percentage No of patients Percent
with side
with side
effects*
effects*
After 1st Dose
Sedation
Sweating
Bleeding at tooth extraction
Diarrhoea
Epigastric Pain
Decrease in B.P.
After 2nd Dose
Sedation
Sweating
Bleeding at tooth extraction site
Diarrhoea
Epigastric Pain
Decrease in B.P.
3rd Dose
Sedation
Sweating
Bleeding at tooth extraction site
Diarrhoea
Epigastric Pain
Decrease in B.P.
4th Dose
Sedation
Sweating
Bleeding at tooth extraction site
Diarrhoea
Epigastric Pain
Decrease in B.P.
* Each group contains total number of 75 patients
Journal of College of Medical Sciences-Nepal, 2010, Vol. 6, No. 1 Figure 2(a): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac
after 1st dose
Figure 2(b): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac
after 2nd dose
M M Shaik et al. Comparative study of Tramadol and Ketorolac in the pain management of third molar tooth extraction Figure 2(d): Graphical representation – Comparison of Adverse effects of Tramadol and Ketorolac
after 4th dose

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