Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00187135
First received: September 12, 2005
Last updated: March 3, 2015
Last verified: March 2010
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 

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 
Withdrawal by Subject                0                1                1                2                0                0 
Study Discontinued                7                6                7                7                7                6 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[1] All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics.
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. ]

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. ]

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. ]

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. ]

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. ]

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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: 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: March 3, 2015
Health Authority: United States: Institutional Review Board