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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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: Anesthesia 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:

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 [ Time Frame: Until time of discharge from the recovery room followed by a phone evaluation within 7 days. ] [ Designated as safety issue: Yes ]
To study and determine which combinations of fentanyl, propofol, and EMLA or L.M.X4™ achieve the best pain control for these procedures [ Time Frame: Until time of discharge from the recovery room followed by a phone evaluation within 7 days. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	185
Study Start Date:	March 2002
Estimated Study Completion Date:	August 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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.
3: Placebo Comparator 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.

Eligibility

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

Criteria

Inclusion Criteria:

Age: 2-17 years old.
Subjects undergoing bone marrow aspiration (unilateral) with lumbar puncture and intrathecal chemotherapy.
Subjects with acute lymphoblastic leukemia or lymphoblastic lymphoma in remission or are having anticipated remission procedures occurring at the end of remission induction.

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:	St. Jude Children's Research Hospital ( Doralina L. Anghelescu, MD / Principal Investigator )
Study ID Numbers:	PFE
Study First Received:	September 12, 2005
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00187135 History of Changes
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:

Anesthetics, Intravenous
Fentanyl
EMLA
Hematologic Diseases
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Anesthetics, Combined
Anesthetics, General
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Peripheral Nervous System Agents
Analgesics
Bone Marrow Diseases
Propofol
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 25, 2009