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

Primary Purpose

Bone Marrow Disease, Pain

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fentanyl
EMLA
L.M.X4
Propofol
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Disease focused on measuring Pain Management, Bone Marrow Aspiration

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Fentanyl-1mcg/kg in 3 ml of Normal Saline

Fentanyl - 0.5 mcg/kg in 3 ml normal saline

normal saline

Outcomes

Primary Outcome Measures

Pain(Yes/No)
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)
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.

Secondary Outcome Measures

20% or Greater Change in Heart Rate
Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.
20% or Greater Change in Respiratory Rate
Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.
20% or Greater Change in Blood Pressure
Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.
Movement
Movement (yes/no) measured during recovery after surgery.

Full Information

First Posted
September 12, 2005
Last Updated
April 3, 2017
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00187135
Brief Title
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Official Title
Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to slow accrual.
Study Start Date
March 2002 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Disease, Pain
Keywords
Pain Management, Bone Marrow Aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Fentanyl-1mcg/kg in 3 ml of Normal Saline
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fentanyl - 0.5 mcg/kg in 3 ml normal saline
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
normal saline
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl - 1 mcg/kg in 3 ml normal saline Fentanyl - 0.5 mcg/kg in 3 ml normal saline
Intervention Type
Drug
Intervention Name(s)
EMLA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
L.M.X4
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain(Yes/No)
Description
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.
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.
Title
Pain (Yes/No)
Description
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.
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.
Secondary Outcome Measure Information:
Title
20% or Greater Change in Heart Rate
Description
Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.
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.
Title
20% or Greater Change in Respiratory Rate
Description
Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.
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.
Title
20% or Greater Change in Blood Pressure
Description
Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.
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.
Title
Movement
Description
Movement (yes/no) measured during recovery after surgery.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doralina L. Anghelescu, M.D.
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

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

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