Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

Study Overview
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Brief Summary
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The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. Secondary hypotheses state that propofol-fentanyl sedation results in a better sedation induction, recovery profile and is preferred by patients/families. The study is a double blind, randomized, placebo controlled crossover study. Following the induction phase of chemotherapy, children will be randomized in a crossover manner to receive either fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied on two separate occasions, once with propofol-placebo (normal saline) and once with propofol-fentanyl. Children will be monitored continuously by pulse oximetry, electrocardiogram (ECG) and direct nursing and physician observation during the sedation in accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7 for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be recorded every 3 minutes by a study investigator during sedation.

Official Title
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Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: Propofol-Fentanyl
* Drug: Propofol alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children ages 2 years to 18 years with acute leukemia/lymphoma cared for by physicians in the Division of Hematology/Oncology in the Department of Pediatrics and receiving sedation for diagnostic/therapeutic lumbar punctures (LPs) in the UW Pediatric Sedation Program Enrollment will occur after the induction phase of chemotherapy. Exclusion Criteria: American Society of Anesthesiology score ≥ 3 Cardiorespiratory instability Allergy to propofol or its components Age less than 2 years Patients receiving other sedative analgesics Patients with an oxygen requirement

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol-Fentanyl|nan|
|Drug: Propofol alone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient/family preference, ease of induction, and recovery pattern |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, acute leukemia/lymphoma