Intravenous sedation drug shows promise from results of clinical dental trial

Jan. 17, 2014
Dental sedation has been in the news. Sometimes bad. Sometimes good. The current issue of the journal Anesthesia Progress reports on a drug from a clinical trial that shows promise for safe and effective intravenous sedation.

Dental sedation has been in the news. Sometimes bad. Sometimes good. Sometimes probing questions that make us think. And more questions.

Consumer demand for outpatient dental procedures is increasing (1) and, along with it, the requirement for sedatives that meet the needs of patients and dentists. The current issue of the journal Anesthesia Progress published a study of two intravenous sedation drugs, midazolam and fospropofol, in a clinical trial involving patients who underwent oral surgery anticipated to last 30 to 60 minutes with local anesthesia and IV moderate sedation. Results from the study hold promise for fospropofol as a means of safe and effective intravenous sedation. (2)

For the study, 60 patients were randomly selected to receive either midazolam or fospropofol. Both drugs were paired with fentanyl and local anesthesia, and each was evaluated based on these criteria: the onset and maintenance of sedation, safety, cardiovascular stability, time to patient recovery, adverse effects, and patient and surgeon satisfaction.

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According to the report, there were no significant differences in sedation maintenance, safety, or patient and surgeon satisfaction between the two drugs. Both drugs relieve anxiety and provide sedation, but midazolam can be slow to take effect. Results from the trial show fospropofol to have a quicker reaction time, with patients recovering quicker physically as well. There was no significant difference in cognitive recovery times.

As to significant adverse effects, more patients receiving midazolam experienced an increased heart rate, whereas more patients receiving fospropofol reported perineal discomfort. Patients receiving fospropofol also had a higher rate of local anesthetic injection recall. Although fospropofol appears to be a safe alternative to midazolam when administered by anesthesia-trained dentists, such side effects may preclude it completely replacing midazolam.

1. Allen Press, Inc.
2. Yen P, Prior S, Riley C, Johnston W, Smiley M, Thikkurissy S. A comparison of fospropofol to midazolam for moderate sedation during outpatient dental procedures. Anesthesia Progress. Winter 2013; 60(4)162-177.
Allen Press, Inc.

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