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

• Status: Terminated
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Treatments: EMLA; Fentanyl; Propofol

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