University of Wisconsin
Madison, Wisconsin, 53792, United States
NCT Number: NCT00214370
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.
Looking for future studies?
Notify Me2 year–18 year
All sexes
Interventional
Not applicable
Madison, Wisconsin, 53792, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
University of Wisconsin, Madison
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06026046
Hematologic Diseases, Hemic and Lymphatic Diseases
Angers, France
View Trial DetailsNCT05763563
Hematologic Diseases, Hemic and Lymphatic Diseases
Tampa, Florida, United States
View Trial DetailsNCT01315132
Blood Protein Disorders, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT04026737
Cardiotoxicity, Cardiovascular Diseases
Philadelphia, Pennsylvania, United States
View Trial Details