Skip to main content

Advertisement

Log in

Safety of adjunct pre-emptive intravenous tramadol with midazolam sedation for third molar surgery

  • Original Article
  • Published:
Oral and Maxillofacial Surgery Aims and scope Submit manuscript

Abstract

Purpose

The purpose of this study was to evaluate patient safety, in terms of adverse events, alterations in blood pressure or oxygen saturation (SpO2) in two routine sedation procedures, with and without intravenous analgesia.

Methods

Patients referred for surgical removal of mandibular third molars were treated in a randomized, controlled, single-blinded procedure. Eighty-seven men and women, aged 18 to 44 years, were allotted to either of two treatment groups, midazolam + tramadol (M + T) and midazolam + saline (M + S) or to a control group (C), given no sedation.

Results

Tramadol at 1 mg/kg body weight resulted in a higher frequency of oxygen desaturation (SpO2 < 90 %) than a placebo (p = 0.002) but had no effect on mean SpO2 at the end point or at the end of surgery. In both the test groups, there was a significant decrease in diastolic blood pressure (p < 0.001) from baseline to the end of surgery.

Conclusion

The results confirm that pre-emptive intravenous tramadol, administered at 1 mg/kg body weight as an adjunct to midazolam sedation for third molar surgery, offers a safe method. But, it should be noted that our previous study shows that it is not a particularly effective analgesic. Further testing is therefore warranted, using other doses or other drugs, to find a better intravenous protocol for postoperative analgesia, with maximum effect and minimal risk, in outpatient oral and maxillofacial surgery procedures.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Liedholm R (2005) Mandibular third molar removal. Thesis. University of Malmö, Sweden

  2. Seymore RA, Meechan JG, Blair GS (1985) An investigation into postoperative pain and third molar surgery under local analgesia. Br J Oral Maxillofac Surg 23:410–418

    Article  Google Scholar 

  3. Fischer SE, McEntegart DJ (1988) Factors affecting the onset and severity of pain following the surgical removal of unilateral impacted mandibular third molar teeth. Br Dent J 164:351–354

    Article  Google Scholar 

  4. Meechan JG, Seymour RA (1993) The use of third molar surgery in clinical pharmacology. Br J Oral Maxillofac Surg 31:360–365

    Article  CAS  PubMed  Google Scholar 

  5. Lundgren S (1985) Sedation regimen in outpatient oral surgery. Thesis, University of Umeå, Sweden

  6. Rune J, Ström C (1996) Midazolam intravenous conscious sedation in oral surgery. Swed Dent J 20:29–33

    Google Scholar 

  7. Roelofse JA, Van der Bijl P (1994) Cardiac dysrhythmias associated with intravenous lorazepam, diazepam and midazolam during oral surgery. J Oral Maxillofac Surg 52:247–250

    Article  CAS  PubMed  Google Scholar 

  8. Dionne RA, Yagiela JA, More PA, Gonty A, Zuniga J, Beirne R (2001) Comparing efficacy and safety of four intravenous sedation regimens in dental outpatients. JADA 132:740–750

    CAS  PubMed  Google Scholar 

  9. Zacharias M, MacD Hunter K, Parkinson R (1996) Respiratory effects of intravenous midazolam. N Z Dent J 92:76–79

    CAS  PubMed  Google Scholar 

  10. Hardeman JH, Sabol SR, Goldwasser MS (1990) Incidence of hypoxemia in the postanesthetic recovery room in patients having undergone intravenous sedation for outpatient oral surgery. J Oral Maxillofac Surg 48:942–944

    Article  CAS  PubMed  Google Scholar 

  11. Becker DE (2012) Pharmacodynamic considerations for moderate and deep sedation. Anesth Prog 59:28–42

    Article  PubMed Central  PubMed  Google Scholar 

  12. Pozos AJ, Martinez R, Aguirre P (2007) Tramadol administered in combination of routes for reducing pain after removal of an impacted mandibular third molar. J Oral Maxillofac Surg 65:1633–1639

    Article  PubMed  Google Scholar 

  13. Kanto D, Salo M, Happonen RP, Vahlberg T, Kanto J (2005) Tramadol premedication in operative extraction of the mandibular third molar: a placebo-controlled crossover study. Acta Odontol Scand 63:43–49

    CAS  PubMed  Google Scholar 

  14. Ong KS, Lirk P, Tan J, Sow B (2005) The analgesic efficacy of intravenous versus oral tramadol for preventing postoperative pain after third molar surgery. J Oral Maxillofac Surg 63:1162–1188

    Article  PubMed  Google Scholar 

  15. Richmond CE, Bromely LM, Woolf CJ (1993) Preoperative morphine pre-empts postoperative pain. Lancet 342:73–75

    Article  CAS  PubMed  Google Scholar 

  16. Kiss I, Killan M (1992) Does opiate premedication influence postoperative analgesia? A prospective study. Pain 48:157–158

    Article  CAS  PubMed  Google Scholar 

  17. Eriksson L, Tegelberg A (2013) Analgesic efficacy and clinical acceptability of adjunct pre-emptive intravenous tramadol in midazolam sedation for third molar surgery. Oral Maxillofac Surg 17:193–199

    Article  PubMed  Google Scholar 

  18. Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL (1990) Validity and reliability of the observer’s assessment of alertness/sedation scale: study with intravenous sedation. J Clin Pharmacol 4:244–251

    Google Scholar 

  19. Liu J, Singh H, White P (1996) Electroencephalogram bispectral analysis predicts the depth of midazolam-induced sedation. Anaesthesiology 84:64–69

    Article  CAS  Google Scholar 

  20. Malviya T, Voepel-L AR, Tait AR, Merkel S, Tremper K, Naughton N (2002) Depth of sedation in children undergoing computed tomography: validity and reliability of the University of Michigan sedation scale (UMSS). Br J Anaesth 88:241–245

    Article  CAS  PubMed  Google Scholar 

  21. Dripps RD (1963) New classification of physical status. Anesthesiol 24:111

  22. Owens WD, Felts JA, Spitzagel EL (1978) ASA physical status classification. Anaesthesiology 49:239–243

    Article  CAS  Google Scholar 

  23. Moore A, Collins S, Carroll D, McQuay H, Edwards J (2000) Singledose paracetamol (acetaminophen), with and without codeine, for postoperative pain. The Cochrane database Syst Rev 2:CD001547

  24. Rhoda Lee C, McTavish D, Sorkin EM (1993) Tramadol. A preliminary review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in acute and chronic pain states. Drugs 46(2):313–340

    Article  Google Scholar 

  25. Holm SW, Cunningham LL, Bensadoun E, Madsen MJ (2006) Hypertension: classification, pathophysiology, and management during outpatient sedation and local anesthesia. J Oral Maxillofac Surg 64:111–121

    Article  PubMed  Google Scholar 

  26. Taguchi T, Fukuda KI, Sekine H, Kakizawa T (2011) Intravenous sedation and hemodynamic changes during dental implant surgery. Int J Oral Maxillofac Implants 26:1303–1308

    PubMed  Google Scholar 

  27. D’Ermano EM, Bontempi WJ, Howard JB (2008) Anesthesa morbidity and mortality experience among Massachusetts oral and maxillofacial surgeons. J Oral Maxillofac Surg 66:2421–2433

    Article  Google Scholar 

  28. Rodgers SF, Rodgers MS (2011) Safety of intravenous sedation administered by the operating oral surgeon: the second 7 years of practice. J Oral Maxillofac Surg 69:2525–2529

    Article  PubMed  Google Scholar 

  29. Cossman M, Kohnen C, Langford R, McCartney C (1997) Tolerance and safety of tramadol use. Results of international studies and data from drug surveillance. Drugs 53(suppl 2):50–62

    Article  Google Scholar 

  30. Grond S, Sablotzki A (2004) Clinical pharmacology of tramadol. Clin Pharmacokinetic 43(13):879–923

    Article  CAS  Google Scholar 

  31. Beckley ML (2005) Management of postoperative nausea and vomiting: the case of symptomatic treatment. J Oral Maxillofac Surg 63:1528–1530

    Article  PubMed  Google Scholar 

  32. Choi CH (2012) Safety and prevention of complications in endoscopic sedation. Dig Dis Sci 57:1745–1747

    Article  PubMed  Google Scholar 

  33. Langely PC, Patkar AD, Boswell KA, Benson CJ, Schein JR (2010) Review Adverse event profile of tramadol in recent clinical studies of chronic osteoarthritis pain. Curr Med Res Opin 1:239–251

    Article  Google Scholar 

  34. Domi R, Laho H (2012) Anesthetic challenges in obese patient. J Anesth 26:758–765

    Article  PubMed  Google Scholar 

  35. Todd DW (2005) Anesthetic considerations for the obese and morbidly obese oral and maxillofacial surgery patient. J Oral Maxillofac Surg 63:1348–1353

    Article  PubMed  Google Scholar 

  36. Cillo JE, Finn R (2006) Correlation and comparison of body mass index on hemodynamics in hypertensive and normotensive undergoing intravenous sedation. J Oral Maxillofac Surg 64:583–588

    Article  PubMed  Google Scholar 

  37. Collins M, Young I, Sweeney P, Fenn GC, Stratford ME, Wilson A, Harris M (1997) The effect of Tramadol on dento-alveolar surgical pain. Br J Oral Maxillofac Surg 35:54–58

    Article  CAS  PubMed  Google Scholar 

  38. Coulthard P, Snowdon AT, Rood JP (1996) The efficacy and safety of postoperative pain management with Tramadol for day case surgery. Ambul Surg 4:25–29

    Article  Google Scholar 

  39. Mattia C, Coluzzi F, Sarzi Puttini P, Viganó R (2008) Paracetamol/tramadol association: the easy solution for mild-moderate pain. Minerva Med 99:369–390

    CAS  PubMed  Google Scholar 

  40. Duthie DJ (1998) Remifentanil and tramadol. Br J Anaesth 81:51–57

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

The authors thank research nurses Annelie Carlsson and Marie Svensson, for their professional commitment and invaluable role in the clinical conduct of the study as well as their excellent performance of every task.

Jan Ifver is acknowledged for his professional help with statistics.

The authors acknowledge financial support from the Dental Board of the County of Dalarna, Sweden.

Compliance with ethical standards

Conflict of interest

None.

Research involving human participants

The clinical study protocol, patient information sheet, and informed consent form were approved by the regional ethics committee of Uppsala University, Uppsala, Sweden (DNr: 2005:281) and the Swedish National Medical Products Agency (MPA) DNr:151:2007/48722). The study has thereby fulfilled national and European requirements of the Helsinki Declaration by The World Medical Association (WMA), European Medicines Agency (EMEA), European Clinical Trials (EudraCT), and Good Clinical Practice (GCP).

Informed consent

All patients signed the informed consent form at screening before any study-specific procedures commenced.

Monitoring

The study was monitored by an independent observer on four separate occasions during the study period.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Lars B. Eriksson.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Eriksson, L.B., Tegelberg, Å. Safety of adjunct pre-emptive intravenous tramadol with midazolam sedation for third molar surgery. Oral Maxillofac Surg 19, 353–359 (2015). https://doi.org/10.1007/s10006-015-0502-9

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10006-015-0502-9

Keywords

Navigation