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Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
This study is ongoing, but not recruiting participants.
Study NCT00187135   Information provided by St. Jude Children's Research Hospital
First Received: September 12, 2005   Last Updated: June 2, 2008   History of Changes

September 12, 2005
June 2, 2008
March 2002
August 2008   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Until time of discharge from the recovery room followed by a phone evaluation within 7 days. ] [ Designated as safety issue: Yes ]
  • To study and determine which combinations of fentanyl, propofol, and EMLA or L.M.X4™ achieve the best pain control for these procedures [ Time Frame: Until time of discharge from the recovery room followed by a phone evaluation within 7 days. ] [ Designated as safety issue: Yes ]
  • 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.
Complete list of historical versions of study NCT00187135 on ClinicalTrials.gov Archive Site
 
 
 
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study

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 III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
  • Bone Marrow Disease
  • Pain
  • Drug: Fentanyl
  • Drug: EMLA
  • Drug: L.M.X4
  • Drug: Propofol
  • Active Comparator: Fentanyl-1mcg/kg in 3 ml of Normal Saline
  • Active Comparator: Fentanyl - 0.5 mcg/kg in 3 ml normal saline
  • Placebo Comparator: normal saline
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
185
August 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187135
Doralina L. Anghelescu, MD / Principal Investigator, St. Jude Children's Research Hospital
PFE
St. Jude Children's Research Hospital
 
Principal Investigator: Doralina L. Anghelescu, M.D. St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP