Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
St. Jude Children's Research Hospital
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.
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients undergoing bone marrow aspiration (unilateral), with lumbar puncture and intrathecal chemotherapy.
Age 2 to 17 years
ASA I-III
Patients with acute lymphoblastic leukemia or lymphoblastic lymphoma in remission or on the day of anticipated remission procedures occurring at the end of remission induction.
Patients must have three anticipated bone marrow aspirates and lumbar punctures with intrathecal chemotherapy remaining in their treatment
You may not be if
Newly diagnosed patients
Patients with low platelet count (less than 50000)
Patients undergoing bone marrow biopsy in addition to bone marrow aspiration
Age less than 2 years or over 17 years
ASA IV-V
Patients taking opioid medication for pre-existent pain for more than 2 weeks at the time of the procedure
Neurological impairment that would increase susceptibility to opioids (Down's syndrome)
Clinical contraindications for general anesthesia (large mediastinal mass) or specific use of propofol, Fentanyl, EMLA, L•M•X 4™ or Lidocaine for injection
Clareo Health | Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration