Variation in administration of cyclophosphamide and mesna in the treatment of childhood malignancies.

The objective of this study was to describe the variation in preparation and administration of cyclophosphamide, mesna, and hydration for the treatment of childhood malignancies within clinical trial protocol documents. All cyclophosphamide-containing cooperative group (Pediatric Oncology Group) protocols that were open at Dana-Farber Cancer Institute in April 1998 were evaluated. Among the 14 active protocols, there were 23 unique cyclophosphamide regimens. Marked variation existed in infusion rate, fluid type, and volume used for admixing cyclophosphamide and mesna, as defined in the "Treatment" section of the protocols that we evaluated. Further variation was found in the type, amount, and rate of infusion of prehydration and posthydration fluid. Internal inconsistency existed within the protocols pertaining to the administration methods described in the "Agent Information," "Treatment," and "Consent" sections of the written documents. Clinical trial protocol documents serve as reference material for health care providers who prescribe, dispense, and administer protocol chemotherapy. Misinterpretation of protocol documents and clinician orders are contributing factors in serious and deadly medication errors. Internal inconsistency within protocol documents and variation in drug administration across protocols is a potential source of error. We recommend improved accuracy, clarity, and internal consistency of protocol documents to improve patient safety and compliance with protocol specifications. In addition, the use of standard concentrations, volumes, and methods of administration of chemotherapeutic agents and accompanying fluids is recommended.

Midazolam for conscious sedation during pediatric oncology procedures: safety and recovery parameters.

Multiple bone marrow aspirations or biopsies and lumbar punctures are a necessary part of the diagnosis and treatment of many pediatric cancer patients. Pharmacologic sedation may decrease the distress associated with these procedures. Midazolam (MDZ, Versed) is a water-soluble, rapid-onset, short-duration benzodiazepine that has not been studied widely in children. We prospectively evaluated safety and recovery parameters for intravenous MDZ used for conscious sedation by oncologists (without an anesthesiologist in attendance) for 70 procedures (bone marrow aspirations, lumbar punctures, or bone marrow aspirations plus lumbar punctures) in 24 ambulatory pediatric cancer patients, aged 1.5 to 15.5 years. MDZ was used alone or in combination with morphine or fentanyl. Respiratory rate, oxygen saturation, blood pressure, and heart rate were monitored. Sedation, anxiolysis, and recovery were assessed with a behavior score and a modified recovery room discharge score. Restraint was not required in 45% of the procedures. In no case was a respiratory rate less than 12 observed. In nine procedures (13%), an oxygen saturation less than or equal to 90 occurred, all within 10 minutes after the last dose of MDZ. Ten procedures (14%) required verbal stimulation to take deeper breaths. Two patients did not respond immediately to verbal stimulation and received face-mask oxygen. Hypoxemia was not correlated with opioid use. Hypoxemia appears to be related to total MDZ dose and may occur with normal respiratory rates; all cases resolved with verbal stimulation or face-mask oxygen without specific airway maneuvers or assisted ventilation. Heart rate and blood pressure remained stable in all 70 procedures.(ABSTRACT TRUNCATED AT 250 WORDS)