Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Condition: Bone Marrow Disease; Pain
MeSH terms: Bone Marrow Diseases
Intervention: Fentanyl; EMLA; L.M.X4; Propofol
Intervention description: Fentanyl - 1 mcg/kg in 3 ml normal saline
Fentanyl - 0.5 mcg/kg in 3 ml normal saline; All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours.; All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes.; Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.
Intervention MeSH terms: Fentanyl; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 168.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pain Management; Bone Marrow Aspiration

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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