Status:
TERMINATED
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
Bone Marrow Disease
Pain
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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) ch...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00187135
Start Date
March 1 2002
End Date
August 1 2008
Last Update
April 4 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105