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Effects on postoperative nausea and vomiting of nefopam versus fentanyl following bimaxillary orthognathic surgery: a prospective double-blind randomized controlled trial

  • Choi, Eunhye (Department of Dental Anesthesiology, School of Dentistry, Seoul National University) ;
  • Karm, Myong-Hwan (Department of Dental Anesthesiology, Seoul National University Dental Hospital) ;
  • So, Eunsun (Department of Anesthesiology, School of Dentistry, Dankook University) ;
  • Choi, Yoon Ji (Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital) ;
  • Park, Sookyung (Department of Dental Anesthesiology, Seoul National University Dental Hospital) ;
  • Oh, Yul (Department of Anesthesiology and Pain Medicine, Asan Medical Center) ;
  • Yun, Hye Joo (Department of Dental Anesthesiology, Seoul National University Dental Hospital) ;
  • Kim, Hyun Jeong (Department of Dental Anesthesiology, School of Dentistry, Seoul National University) ;
  • Seo, Kwang-Suk (Department of Dental Anesthesiology, School of Dentistry, Seoul National University)
  • Received : 2019.01.20
  • Accepted : 2019.02.24
  • Published : 2019.02.28

Abstract

Background: Postoperative nausea and vomiting (PONV) frequently occurs following bimaxillary orthognathic surgeries. Compared to opioids, Nefopam is associated with lower incidences of PONV, and does not induce gastrointestinal tract injury, coagulopathy, nephrotoxicity, or fracture healing dysfunction, which are common side effects of Nonsteroidal anti-inflammatory drugs. We compared nefopam- and fentanyl-induced incidence of PONV in patients with access to patient-controlled analgesia (PCA) following bimaxillary orthognathic surgeries. Methods: Patients undergoing bimaxillary orthognathic surgeries were randomly divided into nefopam and fentanyl groups. Nefopam 120 mg or fentanyl $700{\mu}g$ was mixed with normal saline to a final volume of 120 mL. Patients were given access to nefopam or fentanyl via PCA. Postoperative pain intensity and PONV were measured at 30 minutes and 1 hour after surgery in the recovery room and at 8, 24, 48, and 72 hours after surgery in the ward. The frequency of bolus delivery was compared at each time point. Results: Eighty-nine patients were enrolled in this study, with 48 in the nefopam (N) group and 41 in the fentanyl (F) group. PONV occurred in 13 patients (27.7%) in the N group and 7 patients (17.1%) in the F group at 8 hours post-surgery (P = 0.568), and there were no significant differences between the two groups at any of the time points. VAS scores were $4.4{\pm}2.0$ and $3.7{\pm}1.9$ in the N and F groups, respectively, at 8 hours after surgery (P = 0.122), and cumulative bolus delivery was $10.7{\pm}13.7$ and $8.6{\pm}8.5$, respectively (P = 0.408). There were no significant differences in pain or bolus delivery at any of the remaining time points. Conclusion: Patients who underwent bimaxillary orthognathic surgery and were given nefopam via PCA did not experience a lower rate of PONV compared to those that received fentanyl via PCA. Furthermore, nefopam and fentanyl did not provide significantly different postoperative pain control.

Keywords

References

  1. Silva AC, O'Ryan F, Poor DB. Postoperative nausea and vomiting (ponv) after orthognathic surgery: A retrospective study and literature review. J Oral Maxillofac Surg 2006; 64: 1385-97. https://doi.org/10.1016/j.joms.2006.05.024
  2. Frost CM, Frost DE. Nursing care of patients in intermaxillary fixation. Heart Lung 1983; 12: 524-8.
  3. Niederhagen B, Braumann B, Dierke-Dzierzon C, Albrecht S. [postoperative pain after interventions in the area of the mouth-jaw-face]. Mund Kiefer Gesichtschir 1997; 1: 229-34. https://doi.org/10.1007/BF03043555
  4. Park S, Chi SI, Seo KS, Kim HJ. Circadian variation of iv pca use in patients after orthognathic surgery - a retrospective comparative study. J Dent Anesth Pain Med 2015; 15: 141-6. https://doi.org/10.17245/jdapm.2015.15.3.141
  5. Aoki Y, Yoshida K, Nishizawa D, Kasai S, Ichinohe T, Ikeda K, et al. Factors that affect intravenous patientcontrolled analgesia for postoperative pain following orthognathic surgery for mandibular prognathism. PLoS One 2014; 9: e98548. https://doi.org/10.1371/journal.pone.0098548
  6. Ballantyne JC, Carr DB, Chalmers TC, Dear KB, Angelillo IF, Mosteller F. Postoperative patient-controlled analgesia: Meta-analyses of initial randomized control trials. J Clin Anesth 1993; 5: 182-93. https://doi.org/10.1016/0952-8180(93)90013-5
  7. Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand 2001; 45: 795-804.
  8. George JA, Lin EE, Hanna MN, Murphy JD, Kumar K, Ko PS, et al. The effect of intravenous opioid patientcontrolled analgesia with and without background infusion on respiratory depression: A meta-analysis. J Opioid Manag 2010; 6: 47-54. https://doi.org/10.5055/jom.2010.0004
  9. Tramoni G, Viale JP, Cazals C, Bhageerutty K. Morphinesparing effect of nefopam by continuous intravenous injection after abdominal surgery by laparotomy. Eur J Anaesthesiol 2003; 20: 990-2. https://doi.org/10.1097/00003643-200312000-00013
  10. Rohm KD, Riechmann J, Boldt J, Schuler S, Suttner SW, Piper SN. Physostigmine for the prevention of postanaesthetic shivering following general anaesthesia - a placebo-controlled comparison with nefopam. Anaesthesia 2005; 60: 433-8. https://doi.org/10.1111/j.1365-2044.2005.04157.x
  11. Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth 2012; 108: 423-9. https://doi.org/10.1093/bja/aer505
  12. McLintock TT, Kenny GN, Howie JC, McArdle CS, Lawrie S, Aitken H. Assessment of the analgesic efficacy of nefopam hydrochloride after upper abdominal surgery: A study using patient controlled analgesia. Br J Surg 1988; 75: 779-81. https://doi.org/10.1002/bjs.1800750818
  13. Lee JH, Kim JH, Cheong YK. The analgesic effect of nefopam with fentanyl at the end of laparoscopic cholecystectomy. Korean J Pain 2013; 26: 361-7. https://doi.org/10.3344/kjp.2013.26.4.361
  14. Kim YA, Kweon TD, Kim M, Lee HI, Lee YJ, Lee KY. Comparison of meperidine and nefopam for prevention of shivering during spinal anesthesia. Korean J Anesthesiol 2013; 64: 229-33. https://doi.org/10.4097/kjae.2013.64.3.229
  15. Bhatt AM, Pleuvry BJ, Maddison SE. Respiratory and metabolic effects of oral nefopam in human volunteers. Br J Clin Pharmacol 1981; 11: 209-11. https://doi.org/10.1111/j.1365-2125.1981.tb01126.x
  16. Kim K, Kim WJ, Choi DK, Lee YK, Choi IC, Sim JY. The analgesic efficacy and safety of nefopam in patientcontrolled analgesia after cardiac surgery: A randomized, double-blind, prospective study. J Int Med Res 2014; 42: 684-92. https://doi.org/10.1177/0300060514525351
  17. Yoon JU, Byeon GJ, Cheon JH, Choi YM, Ri HS, Baik SW. Post-operative intravenous patient-controlled analgesic efficacy of morphine with ketorolac versus nefopam after laparoscopic gynecologic surgery: A randomized noninferiority trial. Korean J Anesthesiol 2016; 69: 161-6. https://doi.org/10.4097/kjae.2016.69.2.161
  18. Su B, O'Connor JP. Nsaid therapy effects on healing of bone, tendon, and the enthesis. J Appl Physiol (1985) 2013; 115: 892-9. https://doi.org/10.1152/japplphysiol.00053.2013
  19. Marquez-Lara A, Hutchinson ID, Nunez F, Jr., Smith TL, Miller AN. Nonsteroidal anti-inflammatory drugs and bone-healing: A systematic review of research quality. JBJS Rev 2016; 4.
  20. Baht GS, Nadesan P, Silkstone D, Alman BA. Pharmacologically targeting beta-catenin for nf1 associated deficiencies in fracture repair. Bone 2017; 98: 31-6. https://doi.org/10.1016/j.bone.2017.02.012
  21. Grass JA. Patient-controlled analgesia. Anesth Analg 2005; 101: S44-61. https://doi.org/10.1213/01.ANE.0000177102.11682.20
  22. Dawson R, von Fintel N, Nairn S. Sedation assessment using the ramsay scale. (cover story). Emergency Nurse 2010; 18: 18-20. https://doi.org/10.7748/en2010.06.18.3.18.c7825
  23. Precious DS, Multari J, Finley GA, McGrath P. A comparison of patient-controlled and fixed schedule analgesia after orthognathic surgery. J Oral Maxillofac Surg 1997; 55: 33-9; discussion 40. https://doi.org/10.1016/S0278-2391(97)90442-0
  24. Shin TJ, Park Y, Seo K-S, Han HJ, Kim HJ. Surgical invasiveness is important for determining severity of postoperative pain after oral & maxillofacial surgery. J Korean Dent Soc Anesthesiol 2011; 11: 9-15. https://doi.org/10.17245/jkdsa.2011.11.1.9
  25. Gold BS, Kitz DS, Lecky JH, Neuhaus JM. Unanticipated admission to the hospital following ambulatory surgery. JAMA 1989; 262: 3008-10. https://doi.org/10.1001/jama.1989.03430210050028
  26. Rodrigo C, Campbell R, Chow J, Tong A. The effect of a 4-mg preoperative intravenous dose of ondansetron in preventing nausea and vomiting after maxillofacial surgery. J Oral Maxillofac Surg 1996; 54: 1171-5. https://doi.org/10.1016/S0278-2391(96)90343-2
  27. Gray AM, Nevinson MJ, Sewell RD. The involvement of opioidergic and noradrenergic mechanisms in nefopam antinociception. Eur J Pharmacol 1999; 365: 149-57. https://doi.org/10.1016/S0014-2999(98)00837-1
  28. Rosland JH, Hole K. The effect of nefopam and its enantiomers on the uptake of 5-hydroxytryptamine, noradrenaline and dopamine in crude rat brain synaptosomal preparations. J Pharm Pharmacol 1990; 42: 437-8. https://doi.org/10.1111/j.2042-7158.1990.tb06587.x
  29. Fuller RW, Snoddy HD. Evaluation of nefopam as a monoamine uptake inhibitor in vivo in mice. Neuropharmacology 1993; 32: 995-9. https://doi.org/10.1016/0028-3908(93)90064-A
  30. Dordoni PL, Della Ventura M, Stefanelli A, Iannace E, Paparella P, Rocca B, et al. Effect of ketorolac, ketoprofen and nefopam on platelet function. Anaesthesia 1994; 49: 1046-9. https://doi.org/10.1111/j.1365-2044.1994.tb04352.x
  31. Michael R, Younan N, Aziz M, Mostafa N, Ghobriel A, Gintautas J. Effect of a non-opiate analgesic, nefopam hydrochloride, on stress gastric ulcer in rats. Proc West Pharmacol Soc 2001; 44: 109-11.
  32. Alfonsi P, Adam F, Passard A, Guignard B, Sessler DI, Chauvin M. Nefopam, a nonsedative benzoxazocine analgesic, selectively reduces the shivering threshold in unanesthetized subjects. Anesthesiology 2004; 100: 37-43. https://doi.org/10.1097/00000542-200401000-00010
  33. Kim KH, Abdi S. Rediscovery of nefopam for the treatment of neuropathic pain. Korean J Pain 2014; 27: 103-11. https://doi.org/10.3344/kjp.2014.27.2.103
  34. Du Manoir B, Aubrun F, Langlois M, Le Guern ME, Alquier C, Chauvin M, et al. Randomized prospective study of the analgesic effect of nefopam after orthopaedic surgery. Br J Anaesth 2003; 91: 836-41. https://doi.org/10.1093/bja/aeg264
  35. Mimoz O, Incagnoli P, Josse C, Gillon MC, Kuhlman L, Mirand A, et al. Analgesic efficacy and safety of nefopam vs. Propacetamol following hepatic resection. Anaesthesia 2001; 56: 520-5. https://doi.org/10.1046/j.1365-2044.2001.01980.x
  36. Kapfer B, Alfonsi P, Guignard B, Sessler DI, Chauvin M. Nefopam and ketamine comparably enhance postoperative analgesia. Anesth Analg 2005; 100: 169-74. https://doi.org/10.1213/01.ANE.0000138037.19757.ED
  37. Heel RC, Brogden RN, Pakes GE, Speight TM, Avery GS. Nefopam: A review of its pharmacological properties and therapeutic efficacy. Drugs 1980; 19: 249-67. https://doi.org/10.2165/00003495-198019040-00001
  38. Djerada Z, Fournet-Fayard A, Gozalo C, Lelarge C, Lamiable D, Millart H, et al. Population pharmacokinetics of nefopam in elderly, with or without renal impairment, and its link to treatment response. Br J Clin Pharmacol 2014; 77: 1027-38. https://doi.org/10.1111/bcp.12291
  39. Evans MS, Lysakowski C, Tramer MR. Nefopam for the prevention of postoperative pain: Quantitative systematic review. Br J Anaesth 2008; 101: 610-7. https://doi.org/10.1093/bja/aen267
  40. Oh CS, Jung E, Lee SJ, Kim SH. Effect of nefopamversus fentanyl-based patient-controlled analgesia on postoperative nausea and vomiting in patients undergoing gynecological laparoscopic surgery: A prospective doubleblind randomized controlled trial. Curr Med Res Opin 2015; 31: 1599-607. https://doi.org/10.1185/03007995.2015.1058251
  41. Jin HS, Kim YC, Yoo Y, Lee C, Cho CW, Kim WJ. Opioid sparing effect and safety of nefopam in patient controlled analgesia after laparotomy: A randomized, double blind study. J Int Med Res 2016; 44: 844-54. https://doi.org/10.1177/0300060516650783
  42. Kim SY, Huh KH, Roh YH, Oh YJ, Park J, Choi YS. Nefopam as an adjunct to intravenous patient-controlled analgesia after renal transplantation: A randomised trial. Acta Anaesthesiol Scand 2015; 59: 1068-75. https://doi.org/10.1111/aas.12519
  43. Moon JY, Choi SS, Lee SY, Lee MK, Kim JE, Lee JE, et al. The effect of nefopam on postoperative fentanyl consumption: A randomized, double-blind study. Korean J Pain 2016; 29: 110-8. https://doi.org/10.3344/kjp.2016.29.2.110
  44. Tirault M, Derrode N, Clevenot D, Rolland D, Fletcher D, Debaene B. The effect of nefopam on morphine overconsumption induced by large-dose remifentanil during propofol anesthesia for major abdominal surgery. Anesth Analg 2006; 102: 110-7. https://doi.org/10.1213/01.ANE.0000181103.07170.15

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