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

This study has been terminated.
(The study was terminated due to slow accrual.)
Sponsor:
Information provided by:
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187135
First received: September 12, 2005
Last updated: April 22, 2010
Last verified: March 2010

September 12, 2005
April 22, 2010
March 2002
August 2008   (final data collection date for primary outcome measure)
  • Pain(Yes/No) [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: Yes ]
    During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure.
  • Pain (Yes/No) [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: Yes ]
    During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure.
  • 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
  • 20% or Greater Change in Heart Rate [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: No ]
    Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.
  • 20% or Greater Change in Respiratory Rate [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: No ]
    Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.
  • 20% or Greater Change in Blood Pressure [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: No ]
    Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.
  • Movement [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] [ Designated as safety issue: No ]
    Movement (yes/no) measured during recovery after surgery.
Not Provided
Not Provided
Not Provided
 
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.

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 and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection).
  • To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The first BMT/LPIT for which patients receive any fentanyl will be used in this comparison.

The study focusses on the following secondary aims:

  • To determine which dose regimen ensures best conditions to perform bone marrow aspiration (lack of motion) and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration.
  • To evaluate the safety and complications for each dose regimen.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bone Marrow Disease
  • Pain
  • Drug: Fentanyl
    1. Fentanyl - 1 mcg/kg in 3 ml normal saline
    2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline
  • Drug: EMLA
    All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours.
  • Drug: L.M.X4
    All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes.
  • Drug: Propofol
    Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.
  • Active Comparator: 1
    Fentanyl-1mcg/kg in 3 ml of Normal Saline
    Interventions:
    • Drug: Fentanyl
    • Drug: EMLA
    • Drug: L.M.X4
    • Drug: Propofol
  • Active Comparator: 2
    Fentanyl - 0.5 mcg/kg in 3 ml normal saline
    Interventions:
    • Drug: Fentanyl
    • Drug: EMLA
    • Drug: L.M.X4
    • Drug: Propofol
  • Placebo Comparator: 3
    normal saline
    Interventions:
    • Drug: EMLA
    • Drug: L.M.X4
    • Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
168
August 2008
August 2008   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00187135
PFE
No
Doralina L. Anghelescu, MD / Principal Investigator, St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Doralina L. Anghelescu, M.D. St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
March 2010

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