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

NCT00187135 | Terminated Phase 3 Results

• 1 other identifier: PFE
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Marrow Disease; Pain

Keywords

Pain Management; Bone Marrow Aspiration

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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 Outcomes (4)

• 20% or Greater Change in Heart Rate

  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.

• 20% or Greater Change in Respiratory Rate

  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.

• 20% or Greater Change in Blood Pressure

  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.

• Movement

  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.

Study Arms (3)

1

ACTIVE COMPARATOR

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

Drug: Fentanyl; Drug: EMLA; Drug: L.M.X4; Drug: Propofol

2

ACTIVE COMPARATOR

Fentanyl - 0.5 mcg/kg in 3 ml normal saline

Drug: Fentanyl; Drug: EMLA; Drug: L.M.X4; Drug: Propofol

3

PLACEBO COMPARATOR

normal saline

Drug: EMLA; Drug: L.M.X4; Drug: Propofol

Interventions

Fentanyl DRUG

1. Fentanyl - 1 mcg/kg in 3 ml normal saline 2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline

1; 2

EMLA DRUG

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.

1; 2; 3

L.M.X4 DRUG

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.

1; 2; 3

Propofol DRUG

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.

1; 2; 3

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Bone Marrow Diseases; Pain; Agnosia

Interventions

Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

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

• Title: Doralina Anghelescu, MD
• Organization: St. Jude Children's Research Hospital

referralinfo@stjude.org

866-278-5833

Study Officials

• Doralina L. Anghelescu, M.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 2002
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 4, 2017
• Results First Posted: March 19, 2010

Record last verified: 2010-03

Locations

US (1)