Fentanyl-Propofol-EMLA or L.M.X4™ Technique for Bone Marrow Aspiration in Pediatric Patients - A Phase III Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Pain(Yes/No)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
1
Fentanyl-1mcg/kg in 3 ml of Normal Saline
干预措施: Fentanyl (Drug)
1
Fentanyl-1mcg/kg in 3 ml of Normal Saline
干预措施: EMLA (Drug)
1
Fentanyl-1mcg/kg in 3 ml of Normal Saline
干预措施: L.M.X4 (Drug)
1
Fentanyl-1mcg/kg in 3 ml of Normal Saline
干预措施: Propofol (Drug)
2
Fentanyl - 0.5 mcg/kg in 3 ml normal saline
干预措施: Fentanyl (Drug)
2
Fentanyl - 0.5 mcg/kg in 3 ml normal saline
干预措施: EMLA (Drug)
2
Fentanyl - 0.5 mcg/kg in 3 ml normal saline
干预措施: L.M.X4 (Drug)
2
Fentanyl - 0.5 mcg/kg in 3 ml normal saline
干预措施: Propofol (Drug)
3
normal saline
干预措施: EMLA (Drug)
3
normal saline
干预措施: L.M.X4 (Drug)
3
normal saline
干预措施: Propofol (Drug)
结局指标
主要结局
Pain(Yes/No)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)