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

Condition(s) targeted: Bone Marrow Disease; Pain

Intervention: Fentanyl (Drug); EMLA (Drug); L.M.X4 (Drug); Propofol (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: St. Jude Children's Research Hospital

Official(s) and/or principal investigator(s):
Doralina L. Anghelescu, M.D., Principal Investigator, Affiliation: St. Jude Children's Research Hospital

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.

Official title: Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Primary outcome:

To study pain control during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal chemotherapy by using a combination of EMLA or L.M.X4™ cream, the analgesic drug fentanyl, and the anesthetic drug propofol

To study and determine which combinations of fentanyl, propofol, and EMLA or L.M.X4™ achieve the best pain control for these procedures

Minimum age: 2 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age: 2-17 years old.

- Subjects undergoing bone marrow aspiration (unilateral) with lumbar puncture and

intrathecal chemotherapy.

- Subjects with acute lymphoblastic leukemia or lymphoblastic lymphoma in remission or

are having anticipated remission procedures occurring at the end of remission induction.

St. Jude Children's Research Hospital, Memphis, Tennessee 38105, United States

St. Jude Children's Research Hospital

Starting date: March 2002
Ending date: August 2008
Last updated: June 2, 2008