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