|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00214370 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Leukemia Lymphoma |
Drug: Propofol-Fentanyl Drug: Propofol alone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma |
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Wisconsin | |
| University of Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
| Principal Investigator: | Gregory Hollman, MD | University of Wisconsin, Madison |
More Information
| Study ID Numbers: | 2003-0470 |
| Study First Received: | September 15, 2005 |
| Last Updated: | July 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00214370 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
pediatric acute leukemia/lymphoma |
|
Fentanyl Physiological Effects of Drugs Anesthetics Leukemia Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics Propofol Lymphoma Analgesics, Opioid Anesthetics, Intravenous Immunoproliferative Disorders |
Neoplasms by Histologic Type Immune System Diseases Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Lymphatic Diseases Neoplasms Anesthetics, General Peripheral Nervous System Agents Lymphoproliferative Disorders Central Nervous System Agents |