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Intravenous Ketorolac Vs Diclofenac for Analgesia After Maxillofacial Surgery

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Intravenous Ketorolac Vs Diclofenac for Analgesia After Maxillofacial Surgery 216 Intravenous ketorolac vs diclofenac for analgesia after Pekka Tarkkila MD PhD, Marjatta Tuominen MD PhD maxillofacial surgery Per H. Rosenberg MD PhD Purpose: To compare the efficacy of the non-steroidal antiin- duction de l'anesthdsie et avant l'incision. Dans le groupe flammatory drugs (NSAID), ketorolac and diclofenac in pre- kdtorolac, la m~me dose intraveineuse a ~td rdp~tde trois fois vention of pain after maxillofacial surgery. avec un intervalle de six heures. Le groupe diclofdnac a regu Methods: Sixty ASA I-II patients (30 in each group) received le diclof~nac 1,0 rag. kg-1 iv apr~s 12 h. L'oxycodone 0,03 randomly, and double blindly either ketorolac 0.4 mg. kg -1 or mg. kg-t iv administrd ~ l'aide d'un systdme autocontr~l~ ser- diclofenac 1.0 mg. kg -t iv after general anaesthesia induction, vait d' analgdsique de sauvetage. before surgical incision. In the ketorolac group, the same dose R~sultat: Deux patients du groupe k~torolac et trois patients was repeated iv three times at six hour intervals. The du groupe diclofdnac n'ont pas eu besoin d'oxycodone pen- diclofenac group patients received diclofenac 1.0 mg.kg -1 dant l'~tude. En moyenne, 12 et 11 doses d'oxycodone ont ~td after 12 hr iv. Rescue analgesic medication consisting of oxy- n~cessaires respectivement dans le groupe k~torolac et dons le codone 0.03 rag. kg-t iv, was administered by a patient con- groupe diclofdnac (NS). Les effets secondaires ont dt~ les trolled analgesia apparatus. m~mes dans les deux groupes. Tousles patients exceptd un ont Results: Two patients in the ketorolac and three patients in the ~t~ satisfaits de leur analgdsie. diclofenac group did not need oxycodone during the study Conclusion: Le kdtorolac (0,4 rag. kg -t quatre fois en 24 h) et period. On average, 12 and 11 doses of oxycodone were need- le diclof~nac (1 rag. kg -s deux fois en 24 h) ont eu le mdme ed in the ketorolac and the diclofenac groups, respectively effet, mais ?t eux seuls ont dtd insuffisants pour procurer (NS). Side-effects were similar in both groups. All patients l'analg~sie apr~s une chirurgie maxillofaciale. except one were satisfied with the pain therapy. Conclusion: Parenteral ketorolac (0.4 mg. kg-t four times in 24 hr) and diclofenac (1 rag. kg-I twice in 24 hr) were similar, Nonsteroidal antiinflammatory drugs (NSAID) have but insufficient alone, for analgesia after maxillofacial been found to be effective in eliminating pain after vari- surgery. ous types of surgery. 1 Although the mechanism of anal- gesic action i.e., inhibition of prostaglandin synthesis Objectif: Comparer l'efficacitd des anti-inflammatoires non (cyclo-oxygenase activity) is the same for all presently stdro~diens kdtotolac et diclofinac pour la prdvention de la used NSAIDs, the analgesic efficacy relative to douleur en chirurgie maxillofaciale. side-effects may vary from agent to agent. 2 Recently, Mdthode: Soixante patients ASA Iet H (30 dans chaque we have showed that pain after maxillofacial surgery groupe), randomisds et en double aveugle, ont regu soit was more effectively reduced by parenterally adminis- kdtorolac 0,4 rag. kg-I soit diclofdnac 1,0 mg. kg-1 aprbs l'in- tered diclofenac than by parenteral ketoprofen. 3 Also, diclofenac has been found to have an opioid-sparing effect after several other types of surgery. 4-6 The most Key words recent parenteral NSAID for the control of postoperative ANESTHETICTECHNIQUES: general; pain is ketorolac. 7'8 The analgesic potency of ketorolac PAIN: postoperative, PCA; 30 mg im has been shown to be comparable with mor- DRUGS: ketorolac, diclofenac. phine 10-12 mg im. 8,9 From the Department of Anaesthesia, 4th Dept of Surgery, Comparative studies between the analgesic efficacy University of Helsinki, Finland. of ketorolac and diclofenac are rare. In cancer pain, Address correspondence to: Dr. Pekka Tarkkila, Depart- ketorolac suppositories (30 mg) were more efficacious ment of Anaesthesia, 4th Dept of Surgery, University of than diclofenac (100 mg), but only for the first 12 hr of Helsinki, Kasarmikatu 11-13, Fin-00130 Helsinki, Finland. treatment. 1~ Also, following arthroscopy of the knee Fax: Int-358-0-654294. joint, ketorolac provided better postoperative analgesia Accepted for publication 5th October, 1995. than diclofenac. 11 On the other hand, after removal of CAN J ANAESTH 1996 / 43:3 / pp216-20 Tarkkila et al.: KETOROLAC VS DICLOFENAC 217 impacted mandibular third molar teeth im ketorolac and TABLE I Patients' characteristicsand types of surgery (mean • SD diclofenac provided a similar degree of pain relief) 2 or numberof patients). Since the type of surgery may influence the efficacy of Ketorolac group Diclofenac group individual NSAIDs on postoperative pain, 2 we found it Age (yr) 30 • 9 33 • 11 worthwhile to compare the postoperative analgesic effi- Height (cm) 172 _+ 8 173 • 8 cacy of ketorolac and diclofenac in a relatively homoge- Weight (kg) 68 • 13 69 • 15 neous population, i.e., patients undergoing maxillofacial Sex (female/male) 18/12 17/13 surgery. Type of operation - osteotomy 20 19 - other bone operation 6 5 Methods - removalof plates 3 4 After obtaining informed consent, 60 ASA I-II patients - soft tissue operation 1 2 scheduled for maxillofacial surgery were randomly Duration of operation (min) 161 • 72 127 • 63 assigned to receive either ketorolac or diclofenac Blood loss (ml) 250 + 320 181 • 250 according to a double-blind protocol design approved by Fentanyl during anaesthesia (mg) 0.5 • 0.2 0.4 • 0.2 the Ethics Committee of the hospital. Patients with a history of allergic reactions to NSAIDs, bronchial asth- ma, gastrointestinal ulceration or bleeding disorders 0.03 mg- kg-I iv (four-hour maximum dose 0.4 mg. kg-1 were excluded from the study. and lock-out time five minutes) was administered Dexamethasone, 4 mg iv was given to osteotomy by a patient controlled analgesia (PCA) apparatus patients three times (with the premedication, during (Lifecare | Abbott, USA). The use of the PCA-device surgery and in the first postoperative night) to reduce was explained to each patient during the preoperative swelling and postoperative inflammation. Premedication visit. The patients were advised to demand analgesic consisted of diazepam 0.15 mg-kg -t po, and oxycodone delivery so often that they would be painfree. The num- 0.14 mg.kg -~ im about 45 min before induction of ber of doses and administration attempts and exact time anaesthesia. After 0.2 mg glycopyrrolate, anaesthesia of administration were recorded. was induced with thiopentone about 5 mg. kg-~ iv and All patients were visited by one of the investigators maintained with enflurane in O2/N20 (30/70%). on the first postoperative day, approximately 24 hr after Tracheal intubation was facilitated with succinylcholine anaesthesia. Subjective side effects, recorded at prede- 1-1.5 mg .kg-~ and muscle relaxation was maintained termined intervals (i.e., during the stay in the recovery with alcuronium. All patients received small incremen- room, on the ward until 9 p.m., and on the ward from 9 tal doses of fentanyl for analgesia. p.m. to the 24-hr interview) were registered. The The ECG, SpO2, PzTCO2, noninvasive arterial blood patients' opinions (graded good, fair or poor) regarding pressure (oscillotonometry) and heart rate were moni- the quality of analgesia and the system drug delivery tored during the anaesthesia. On the first postoperative were also recorded. day, the serum creatinine concentration was measured in the hospital laboratory. Statistics The results are expressed as mean (_SD) (or range). Study drugs Student's t test, Mann-Whitney test, chi-square test and After induction of general anaesthesia, before surgical Fisher's exact tests were used as appropriate. A value of incision, the patients received iv either ketorolac P < 0.05 was considered statistically significant. tromethamine (Toradol| Syntex, Sweden) 0.4 mg. kg-1 iri 100 ml 0.9% NaC1 or diclofenac sodium (Voltaren| Results Ciba Geigy, Basel, Switzerland) 1.0 mg .kg -~ in 100 ml The groups were comparable with respect to demo- 0.9% NaC1. In the ketorolac group, the same iv dose was graphic data and type of maxillofacial surgery (Table I). repeated three times at six hour intervals. There was no difference in the mean amount of periop- In the diclofenac group the patients received placebo erative fentanyl between the groups (Table I) and the (0.9% NaCI) after six hours, diclofenac 1.0 mg-kg -1 amount of intraoperative fentanyl did not correlate with after 12 hr and finally placebo iv after 18 hr. The daily postoperative opioid demands. The number of patients dose of diclofenac was divided into two equal doses. receiving perioperative dexamethasone (osteotomies) Such an administration interval has been found adequate was comparable in both groups (21 vs 19 patients). The by Hodsman and coworkers. 5 No other NSAID medica- recovery period was uneventful in all patients. tion was allowed during the study period. Two patients in the ketorolac (7%) and three patients Rescue analgesic medication consisting of oxycodone in the diclofenac group (10%) did not need any 218 CANADIAN JOURNAL OF ANAESTHESIA TABLEII Meannumber and range of self-administeredoxycodone TABLE III Postoperative side-effects and complaints during the doses (averagedose in mg) and demands during 24 hr study period. study period (number of patients). Time interval Ketorolac group Diclofenac group Ketorolac group Diclofenac group 0-6 hr 2.2 (4.4 mg) 3.6 (7.2 mg) Nausea 11 8 (0-8) (0-14) Vomiting 7 3 6-12 hr 3.8 (7.6 mg) 3.2 (6.4 mg) Dizziness 25 28 (0-11) (0-10) Sleepiness 25 25 12-18 hr 2.8 (5.6 mg) 2.1 (4.2 mg) Pruritus 5 5 (0-9) (0-9) Irritation at venous infusion site 2 3 18-24 hr 3.0 (6.0 mg) 2.2 (4.4 mg) Micturition difficulties 3 6 (0-9) (0-10) Urinary bladder catheterisation 3 2 Total 12 (24 mg) 11 (22 mg) (0-27) (0-27) Number of additional demands (83%) among the study patients is probably the result of during lock-out 1.1 (0-13) 1.0 (0-7) central nervous effects of the NSAIDs, 13'14 and residual sedative effects of anaesthesia and the sedative effect of the concomitantly administered opioid.
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