Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT00187135
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT00187135
Study Brief:
Protocol Section:
NCT00187135