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By Akinbade A.O, Ugboko V.I, Owotade FJ, Ndukwe K.C.

A COMPARATIVE EFFICACY OF IBUPROFEN, CELECOXIB AND TRAMADOL ON POSTOPERATIVE PAIN CONTROL FOLLOWING IMPACTED MANDIBULAR THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED TRIAL. By Akinbade A.O, Ugboko V.I, Owotade FJ, Ndukwe K.C. Department of Oral and Maxillofacial Surgery,

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By Akinbade A.O, Ugboko V.I, Owotade FJ, Ndukwe K.C.

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  1. A COMPARATIVE EFFICACY OF IBUPROFEN, CELECOXIB AND TRAMADOL ON POSTOPERATIVE PAIN CONTROL FOLLOWING IMPACTED MANDIBULAR THIRD MOLAR EXTRACTION: A RANDOMIZED CONTROLLED TRIAL.

  2. By Akinbade A.O, Ugboko V.I, Owotade FJ, Ndukwe K.C. Department of Oral and Maxillofacial Surgery, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.

  3. INTRODUCTION • Surgical extraction of mandibular 3rd molar is one of the commonest surgical procedure in clinical practice. • It involves trauma to soft tissues and bony structures of the oral cavity leading to varying degrees of pain and swelling.

  4. Postoperative pain results from the release of large series of pain mediators activated by inflammatory process caused by surgical trauma. Studies had shown that management of postoperative pain is still a great challenge and far from being satisfactory.

  5. A plethora of analgesics are available for postoperative pain control after 3rd molar surgery : Antipyretic analgesic, Non- steroidal Anti-inflammatory Drugs(NSAIDs) and Opioids. • Ibuprofen is a traditional non-selective NSAID(tNSAID), Celecoxib is a Cyclooxygenase(COX) 2 selective inhibitor and Tramadol is a synthetic weak opiod.

  6. Cyclooxygenase 1 & 2 can initiate the metabolism of arachidonic acid to prostaglandins. • COX- 1 is constitutively present in cells and governs the homeostatic functions necessary to maintain physiological integrity including gastric cytoprotection. • COX-2 is induced in response to inflammatory stimuli and is responsible for inflammation and pain.

  7. All t-NSAIDs inhibits both COX 1 & 2 and are associated with an increased gastrointestinal complications. • COX-2 Selective inhibitors spares the COX-1, its functions are maintained hence no gastrointestinal complications.

  8. Tramadol is a centrally acting analgesic structurally similar to codeine and morphine. • It does not cause marked respiratory depression and GI function is largely unaffected with its administration.

  9. Evidence-based study on efficacy of Ibuprofen, Celecoxib and Tramadol is lacking. • Need for Safe and efficacious alternatives to tNSAIDs is increasing. • The study therefore aimed at comparing the efficacy of Ibuprofen, celecoxib and tramadol.

  10. MATERIALS AND METHODS STUDY DESIGN • The study was a double blind randomized controlled trial to compare the efficacy of Ibuprofen, Celecoxib and Tramadol after impacted mandibular third molar extraction. STUDY POPULATION • The study population consisted of adult participants with impacted mandibular third molars presenting at the Oral Surgery Clinic of the OAUTHC, Ile-Ife, Osun state, Nigeria.

  11. INCLUSION CRITERIA • Participants aged between 18-45 years. • Participants with at least one impacted mandibular third molar indicated for surgical   extraction, confirmed by periapical radiographs. • Participants without any uncontrolled medical or systemic conditions.  • Informed consent from participant including willingness to take part in the study

  12. EXCLUSION CRITERIA 1. Participants with acute infection involving the mandibular third molar in question. 2. Participants with uncontrolled medical or systemic disease contraindicating surgical extraction under local anesthesia e.g. compromised cardiac function, hematological abnormalities, metabolic disorders, central nervous system disorder, impaired renal or hepatic function or depressed respiratory functions.

  13. 3. History of allergy or hypersensitivity to Ibuprofen, Celecoxib and Tramadol. 4. Participants with peptic ulcer disease, pregnancy or breastfeeding. 5. Participants with history of psychological or physical dependence on opioids. 6. History of use of analgesic in the previous 24 hours. 7. Unwillingness of patient to give informed consent.

  14. SAMPLE SIZE • A total of 135 participants requiring the extraction of mandibular third molar who satisfied the inclusion criteria and gave consent were recruited into the study and were randomized into 3 groups of 45 patients.

  15. METHOD PILOT STUDY • A pilot study which recruited 25 participants was carried out over a period of 2 months. They were randomized into 3 groups. The pilot study assisted in

  16. RANDOMIZATION • The appropriate doses of each of the 3 medications were dispensed and kept in non-transparent sealed envelopes as follow: • Tabs Ibuprofen 400mg 8hourly x 48 hrs. • Caps Celecoxib 400mg start, then 200mg 12hourly x 48hrs • Tabs Tramadol 100mg 8hrly x 48hrs.

  17. There were 45 of such envelopes for each of the 3 study groups. There was no inscription of name or symbol on the tablets and capsules or anything that could reveal the identity of any the drugs. This assisted in ensuring the blinding of the participants to the drugs.

  18. Each medication was labeled with a medication code number according to the randomization sequence that has been generated by an independent observer before the commencement of the study.

  19. SURGICAL PROCEDURE • Extractions were done on out-patient basis by a single operator (the investigator) using 2% lignocaine hydrochloride with 1:100,000 adrenaline as the local anaesthetic agent. • All extractions were done using the same technique and armamentarium.

  20. DRUG ADMINISTRATION • The first dose of the enclosed medication was administered immediately after extraction by the independent observer. • Participants were adequately educated on how to take the remaining drugs at home. • Each participant was provided a course of the assigned analgesic free of charge for a 48 hour period.

  21. POSTOPERATIVE PAIN ASSESSMENT • Before the extraction, participants were given a visual analogue scale sheet which comprised of a horizontal line 100mm in length with word descriptors at each end- Point 0 at the left end representing “no pain” and point 100 at the right end representing “worst pain imaginable”.

  22. They were then properly educated on how to record their pain intensity on the visual analogue scale by placing a vertical mark with a pen across the horizontal line of the VAS at the point they felt represented the pain they felt at intervals.

  23. Participants were then asked to record the pain intensity felt before the extraction, immediately after extraction thereafter, serially at 4 hours, 8 hours, 16 hours, 24 hours and 48hours after the extraction using the visual analogue scale.

  24. Participants were also asked to record any side effect or complication of the medication they felt. • Each participant was reviewed with their pain records 24 hours after the surgery, and subsequently at the 7th post-operative day when their VAS recordings are collected.

  25. DATA COLLECTION • A questionnaire was used for the collection of information on each participant . • Information collected in addition to the VAS scores at intervals as stated above, included age, gender, occupation, marital status and educational level

  26. The VAS scores were determined by measuring in millimeters from the left end of the VAS to the point that participant marks.

  27. DATA ANALYSIS • Data analysis was carried out using Stata 10 (Statacorp College Station, Texas). Statistical analysis was done using intention- to- treat analysis.

  28. ETHICAL ISSUES • Ethical clearance for the study was obtained from the Ethical Committee of OAUTHC, Ile-Ife • Written informed consent was freely obtained from each study participant following a clear explanation of the study objective and procedures involved.

  29. RESULTS • A total of 135 participants who presented during the study period (September 2010-August 2011) and met the inclusion criteria for this study constituted the study population. • Their ages ranged from 18-45years with a mean ± SD of 26.51±6.29 years. They were 48 males (35.56%) and 87 females (64.44%) with a male to female ratio of 1:1.8.

  30. These participants were randomized into three groups of 45 each based on the medication they received. • Group A- tramadol tablets. Three participants failed to return the VAS form. • Out of the remaining 42 participants, eight of them discontinued their medications before 48 hours observation period due to unbearable adverse effects of the drug(17.78% drop out rate).

  31. Group B. Participants in this group received Ibuprofen. Four patients failed to return the VAS form. • Out of the remaining 41 participants, two of them discontinued their medication 16 hours after the extraction and one patient at 24 hours after extraction (7.31% drop out rate).

  32. Group C. Participants in this group received Celecoxib. Only one of them discontinue the medication at 24 hours after the extraction.

  33. DESCRIPTIVE CHARACTERISTICS Treatment group VARIABLE Tramadol Ibuprofen Celecoxib Mean age(years 25.75±5.36 27.22±7.13 26.56±6.29 Gender [(freq (%)] Male 15(33.33) 17(37.78) 16(35.56) Female30(66.67) 32(71.11) 29(64.44) Highest Education Primary 1(2.22) 0(0) 1(2.22) Secondary 3(6.67) 6(13.33) 2(4.44) Tertiary 41(91.11) 39(86.67) 41(91.11) No education 0(0) 0(0) 1(2.22) _______________________________________________________________________________

  34. Table 2: Mean pain intensity (VAS) of patients who received Tramadol, Ibuprofen and Celecoxib at different time points. • Variable Tramadol group Ibuprofen group Celecoxib group P value Overall mean • ___________________________________________________________________________________________________________________ • Mean VAS before extraction 17.95±23.61 15.97±22.29 20.06±23.97 0.86 18.52±23.70 • Mean VAS after extraction 28.60±25.22 26.76±26.64 28.60±28.87 0.93 28.00±26.80 • *Mean VAS score at 4 hours 53.26±30.81 38.96±22.30 32.25±23.96 0.0039 41.62±29.51 • Mean VAS score at 8 hours 36.711±27.26 33.36±31.01 27.62±22.30 0.28 32.44±27.01 • Mean VAS score at 16 hours 20.62±20.93 19.02±22.75 19.24±22.34 0.94 19.62±21.86 • Mean VAS score at 24 hours 17.50±20.73 21.72±28.0 12.67±17.77 0.18 17.06±22.54 • Mean VAS score at 48 hours 13.54±19.93 17.42±24.98 9.87±16.11 0.26 13.42±20.53 • *Change in mean VAS at 4 hours 35.31±30.82 21.34±37.1 12.25±32.45 0.0071 • ____________________________________________________________________________________________________________________ • *Change in mean VAS=Mean VAS at 4 hour- Mean VAS before extraction. • * Statistically significant.

  35. COMPARING PAIN INTENSITY IN THE 3 GROUPS AT INTERVALS

  36. BOX AND WHISKER PLOT COMPARING CHANGE IN PAIN INTENSITY 4HRS AFTER EXTRACTION

  37. Table 5: Comparing post operative Mean VAS scores between celecoxib and tramadol groups at different time points after extraction • . • Postop time points Mean VAS(SD) scores Difference P value • Celecoxib group Tramadol group • *4 hours 32.77±27.38 53.26±28.65 -20.49 0.005 • 8 hours 27.62±22.30 36.37±27.27 -9.09 0.29 • 16 hours 19.24±22.34 20.61±20.92 -1.37 0.96 • 24 hours 12.67±17.78 17.5±20.73 -4.83 0.62 • 48 hours 9.87±16.11 13.54±19.93 -3.66 0.73 • Difference = Mean VAS of celecoxib group – Mean VAS of tramadol group • * Statistically significant

  38. Table 4: Comparing post operative Mean VAS scores between Ibuprofen and Tramadol groups at different time points after extraction. • Postop time points Mean VAS (SD) scores Difference P-value • Ibuprofen group Tramadol group • 4 hours 39.22±29.35 53.26±28.65 -14.04 0.084 • 8 hours 33.37±31.01 36.37±27.27 -3.35 0.85 • 16 hours 19.02±22.75 20.61±20.92 -1.59 0.95 • 24 hours 21.72±28.09 17.5±20.73 4.22 0.71 • 48 hours 17.42±24.99 13.54±19.93 3.87 0.72 • Difference = Mean VAS of ibuprofen group – Mean VAS of tramadol group

  39. Table 6: Comparing post operative Mean VAS scores between Celecoxib and Ibuprofen groups at different time points after extraction. • Postop time points Mean VAS (SD) scores Difference P-value • Celecoxib group Ibuprofen group • 4 hours 32.77±27.38 39.22±29.35 -6.45 0.58 • 8 hours 27.62±22.30 33.37±31.01 -5.74 0.616 • 16 hours 19.24±22.34 19.02±22.75 0.22 0.99 • 24 hours 12.67±17.78 21.72±28.09 -9.05 0.19 • 48 hours 9.87±16.11 17.42±24.99 -7.53 0.26 • Difference = Mean VAS of celecoxib group – Mean VAS of ibuprofen group

  40. FRQUENCY OF ADVERSE EFFECTS OF THE DRUGS IN THE GROUPS

  41. Distribution of adverse effect in Tramadol group

  42. DISCUSSION • Postoperative pain still a global challenge • Considered as neglected adverse effect of surgery. • NSAIDs are the most commonly used with varied analgesic effects • Evidence-based proven alternative to t-NSAIDs has become necessary for pateints whose medical conditions contra-indicate their use.

  43. There is paucity of information on comparative efficacy of Ibuprofen, tramadol & Celecoxib. • Zamiri et al compared the analgesic efficacy of the same drugs after mandibular third molar extraction.

  44. They found out that pain severity was lower in ibuprofen than celecoxib and tramadol groups at 4 and 8 hours after extraction. • Tramadol produced the least analgesic effect in their study. • Though the differences were not statistically significant.

  45. The finding of this study that Celecoxib was more efficacious than Ibuprofen and tramadol differs from that of Zamiri et al but agree with Tramadol as the least efficacious of the 3 drugs. • This may be attributable to significant differences in the methodologies and power of the 2 studies.

  46. Cheung and associates in a single dose randomized, double blind, active- and placebo-controlled study found out that mean time to onset of analgesia with celecoxib 400mg and Ibuprofen 400mg are comparable. • Their study,in agreement with the present one also showed that Celecoxib group had lower pain intensity that those in Ibuprofen group.

  47. Loading dose of celecoxib 400mg achieves the plasma concentration needed for early analgesic efficacy and which is maintained by subsequent 12 hourly administration of 200mg. • Ibuprofen does not need a loading dose to achieve plasma concentration for analgesia but has short half life.

  48. Tramadol was the least efficacious in this study in agreement with Zamiri et al. • It does not have anti-inflammatory nor anti-pyretic property hence no effect on prostanglandin synthesis. • Tramadol was the only drug out of the 3 with associated adverse effects.

  49. The multiple doses administered in the present study compared with previous ones allowed: 1. Assessment of the effectiveness of the drugs over a long period of time. 2. Assessment of adverse effects and tolerability of the drugs.

  50. CONCLUSION • The result of this study showed that celecoxib and ibuprofen are more efficacious than tramadol. • Celecoxib however produced better analgesic effect than ibuprofen. • Even though it demonstrated remarkable pain relieving ability after mandibular molar extraction, tramadol was the least efficacious.

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