Pain Clinical Trial
Official title:
Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study
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.
The study focusses on the following primary aims:
- To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have
a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with
EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection).
- To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The
first BMT/LPIT for which patients receive any fentanyl will be used in this comparison.
The study focusses on the following secondary aims:
- To determine which dose regimen ensures best conditions to perform bone marrow
aspiration (lack of motion) and maintains hemodynamic and respiratory stability as
indicators of adequate levels of analgesia during bone marrow aspiration.
- To evaluate the safety and complications for each dose regimen.
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