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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
History of Changes
Results First Received: October 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bone Marrow Disease
Pain
Interventions: Drug: Fentanyl
Drug: EMLA
Drug: L.M.X4
Drug: Propofol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 168 participants were enrolled between March, 2002 and August, 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
168 participants were enrolled and were expected to receive 3 Bone Marrow Aspirations/Lumbar Puncture Intrathecal Chemotherapy procedures; 6 patients withdrew (eg: medical withdrawal, withdrawal of consent and other). 162 were randomized, of which 77 completed all 3 treatments.

Reporting Groups
  Description
Fentanyl 0.5 / Placebo / Fentanyl 1 Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
Fentanyl 0.5 /Fentanyl 1 / Placebo Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
Placebo / Fentanyl 0.5 /Fentanyl 1 Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
Placebo /Fentanyl 1 / Fentanyl 0.5 Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
Fentanyl 1 / Fentanyl 0.5 / Placebo Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
Fentanyl 1 / Placebo /Fentanyl 0.5 Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.

Participant Flow for 3 periods

 Period 1:   Visit One
    Fentanyl 0.5 / Placebo / Fentanyl 1     Fentanyl 0.5 /Fentanyl 1 / Placebo     Placebo / Fentanyl 0.5 /Fentanyl 1     Placebo /Fentanyl 1 / Fentanyl 0.5     Fentanyl 1 / Fentanyl 0.5 / Placebo     Fentanyl 1 / Placebo /Fentanyl 0.5  
STARTED     30     28     25     26     25     28  
COMPLETED     26     27     25     26     25     26  
NOT COMPLETED     4     1     0     0     0     2  
Withdrawal by Subject                 1                 0                 0                 0                 0                 1  
Physician Decision                 3                 1                 0                 0                 0                 1  
Study Discontinued                 0                 0                 0                 0                 0                 0  
Death                 0                 0                 0                 0                 0                 0  

Period 2:   Visit Two
    Fentanyl 0.5 / Placebo / Fentanyl 1     Fentanyl 0.5 /Fentanyl 1 / Placebo     Placebo / Fentanyl 0.5 /Fentanyl 1     Placebo /Fentanyl 1 / Fentanyl 0.5     Fentanyl 1 / Fentanyl 0.5 / Placebo     Fentanyl 1 / Placebo /Fentanyl 0.5  
STARTED     26     27     25     26     25     26  
COMPLETED     21     24     23     18     19     18  
NOT COMPLETED     5     3     2     8     6     8  
Death                 0                 0                 0                 1                 0                 1  
Physician Decision                 1                 0                 0                 0                 0                 0  
Withdrawal by Subject                 1                 1                 1                 0                 1                 1  
Study Discontinued                 3                 2                 1                 7                 5                 6  

Period 3:   Visit Three
    Fentanyl 0.5 / Placebo / Fentanyl 1     Fentanyl 0.5 /Fentanyl 1 / Placebo     Placebo / Fentanyl 0.5 /Fentanyl 1     Placebo /Fentanyl 1 / Fentanyl 0.5     Fentanyl 1 / Fentanyl 0.5 / Placebo     Fentanyl 1 / Placebo /Fentanyl 0.5  
STARTED     21     24     23     18     19     18  
COMPLETED     14     17     14     9     11     12  
NOT COMPLETED     7     7     9     9     8     6  
Death                 0                 0                 1                 0                 1                 0  
Physician Decision                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 1                 1                 2                 0                 0  
Study Discontinued                 7                 6                 7                 7                 7                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Fentanyl 0.5/Placebo/Fentanyl 1 No text entered.
Fentanyl 0.5/Fentanyl 1/Placebo No text entered.
Placebo/Fentanyl 0.5/Fentanyl 1 No text entered.
Placebo/Fentanyl 1/Fentanyl 0.5 No text entered.
Fentanyl 1/Fentanyl 0.5/Placebo No text entered.
Fentanyl 1/Placebo/Fentanyl 0.5 No text entered.
Total Total of all reporting groups

Baseline Measures
    Fentanyl 0.5/Placebo/Fentanyl 1     Fentanyl 0.5/Fentanyl 1/Placebo     Placebo/Fentanyl 0.5/Fentanyl 1     Placebo/Fentanyl 1/Fentanyl 0.5     Fentanyl 1/Fentanyl 0.5/Placebo     Fentanyl 1/Placebo/Fentanyl 0.5     Total  
Number of Participants  
[units: participants]
 		  30     28     25     26     25     28     162  
Age [1]
[units: years]
Mean ± Standard Deviation 		  6.4  ± 4.3     7.2  ± 4.5     7.6  ± 4.8     7.1  ± 4.1     7.3  ± 4.7     7.1  ± 4.4     7.1  ± 4.4  
Gender [1]
[units: participants]
 		             
Female     15     11     12     10     9     13     70  
Male     15     17     13     16     16     15     92  
[1] All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]
  Show Outcome Measure 1

2.  Primary:   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. ]
  Show Outcome Measure 2

3.  Secondary:   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. ]
  Show Outcome Measure 3

4.  Secondary:   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. ]
  Show Outcome Measure 4

5.  Secondary:   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. ]
  Show Outcome Measure 5

6.  Secondary:   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. ]
  Show Outcome Measure 6


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
All 162 participants were expected to receive three treatments. Not all participants received all three treatments. Therefore, analysis required the identification of subsets of treated participants. The trial terminated early due to slow accrual.  


Results Point of Contact:  
Name/Title: Doralina Anghelescu, MD
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org


No publications provided


Responsible Party: Doralina L. Anghelescu, MD / Principal Investigator, St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00187135     History of Changes
Other Study ID Numbers: PFE
Study First Received: September 12, 2005
Results First Received: October 13, 2009
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board