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

Phase 3

Terminated

Conditions: Pain
Bone Marrow Disease

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

Registration Number: NCT00187135

Lead Sponsor: St. Jude Children's Research Hospital

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 168

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Fentanyl	Fentanyl-1mcg/kg in 3 ml of Normal Saline
2	L.M.X4	Fentanyl - 0.5 mcg/kg in 3 ml normal saline
1	L.M.X4	Fentanyl-1mcg/kg in 3 ml of Normal Saline
3	L.M.X4	normal saline
1	EMLA	Fentanyl-1mcg/kg in 3 ml of Normal Saline
2	EMLA	Fentanyl - 0.5 mcg/kg in 3 ml normal saline
1	Propofol	Fentanyl-1mcg/kg in 3 ml of Normal Saline
2	Propofol	Fentanyl - 0.5 mcg/kg in 3 ml normal saline
2	Fentanyl	Fentanyl - 0.5 mcg/kg in 3 ml normal saline
3	EMLA	normal saline
3	Propofol	normal saline

Primary Outcome Measures

Name	Time	Method
Pain(Yes/No)	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.	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)	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.	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

Name	Time	Method
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.	Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.
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.	Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.
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.	Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.
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.	Movement (yes/no) measured during recovery after surgery.