drugset / Trial / NCT00187135

Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration

NCT00187135

Phase 3 Terminated 168 enrolled St. Jude Children's Research Hospital
RandomizedCrossoverQuadruple-blindTreatment

Summary

St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control. Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.

Timeline

Start
2002-03
Primary completion
2008-08
Completion
2008-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 0.5 ug/kg
Comparator Fentanyl Other / unclassified 1 ug/kg
Comparator EMLA Unknown Topical
Comparator LMX4 Unknown Topical
Comparator Propofol Small molecule 1 mg/kg Intravenous

Indications