Comparing efficacy and safety of four intravenous sedation regimens in dental outpatients

Background. Management of patients' fear and anxiety during dental treatmen t is a primary concern of dental practitioners. Pharmacological strategies used in outpatient dental settings must be both safe and effective. Regimen s of intravenously administered sedative drugs were evaluated in a collabor ative, multicenter study of outpatients undergoing removal of impacted thir d molars. Methods. A total of 997 patients randomly received one of five treatments: placebo; midazolam administered to a clinical endpoint of conscious sedatio n (mean dose, 8.6 milligrams); midazolam plus additional midazolam as neede d during the procedure (man total dose 12.2 mg); fentanyl (1.4 micrograms/k ilogram) plus midazolam to achieve the same endpoint of conscious sedation (mean dose, 5.7 mg); or fentanyl (1.4 (mug/kg), midazolam (mean dose, 5.8 m g) and methohexital as needed during the procedure (mean dose, 61.0 mg). Results. Each drug regimen reduced anxiety during surgery in comparison wit h placebo, with the combination of midazolam, fentanyl and methohexital res ulting in significantly less anxiety in comparison with the other treatment groups. Pain reports by patients during surgery also were reduced signific antly by the combination of fentanyl, midazolam and methohexital. Patients' global evaluations of the efficacy of sedation ranked midazolam with suppl emental midazolam and the combination of fentanyl, midazolam and methohexit al as significantly mor efficacious than the other two drug regimens. The a uthors noted transient respiratory depression in patients in the two opioid -treated groups, but no other physiological changes were detected. Conclusions. These data provide evidence that the drugs and doses evaluated resulted in therapeutic benefit to dental outpatients, with minimal incide nce of potentially serious adverse effects. Clinical Implications. The results of this large-scale study provide assura nce to both the public and the dental profession of the safety of parentera l sedation wit these drugs and combinations of these drugs when titrated sl owly in the recommended doses by appropriately trained dentists.