drugset / Trial / NCT01017237

Dexmedetomidine Sedation With Third Molar Surgery

NCT01017237 ↗

Phase 4 Terminated 18 enrolled University of North Carolina, Chapel Hill
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Intravenous sedation is used frequently for the relief of pain and anxiety associated with oral surgical procedures performed under local anesthesia. The purpose of this study is to learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in combination with midazolam alone or with midazolam plus low dose ketamine while having wisdom teeth removed. The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital operating rooms and has been approved by the US Food and Drug Administration for the use planned in this study.

Timeline

Start
2009-07
Primary completion
2011-12
Completion
2011-12

Outcome

Outcome not reported

Stopped: “Protocol proved to be ineffective for adequate sedation for third molar surgery.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.5 ug/kg Intravenous
Comparator Ketamine Small molecule 0.25 mg/kg Intravenous
Comparator Midazolam Small molecule 0.04 mg/kg Intravenous

Indications

No indication recorded.