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

Sponsor:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00187135

Purpose

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.

Condition	Intervention	Phase
Bone Marrow Disease Pain	Drug: Fentanyl Drug: EMLA Drug: L.M.X4 Drug: Propofol	Phase III

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
Official Title:	Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Diseases

Drug Information available for: Fentanyl Fentanyl Citrate Propofol

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	168
Study Start Date:	March 2002
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Fentanyl-1mcg/kg in 3 ml of Normal Saline	Drug: Fentanyl Fentanyl - 1 mcg/kg in 3 ml normal saline 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: 2 Fentanyl - 0.5 mcg/kg in 3 ml normal saline	Drug: Fentanyl Fentanyl - 1 mcg/kg in 3 ml normal saline 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.
Placebo Comparator: 3 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.

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.

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187135

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Doralina L. Anghelescu, M.D.

St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

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

Keywords provided by St. Jude Children's Research Hospital:

Pain Management
Bone Marrow Aspiration

Additional relevant MeSH terms:

Bone Marrow Diseases
Hematologic Diseases
Fentanyl
Propofol
Anesthetics, Intravenous
EMLA
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics

Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Anesthetics, Combined
Anesthetics, Local

ClinicalTrials.gov processed this record on February 12, 2012