Objective We sought to determine whether the combination of propofol and fentanyl results in lower propofol doses and fewer adverse cardiopulmonary events than propofol and placebo for lumbar puncture (LP) in children with acute hematologic malignancies. Design Randomized, controlled, double blind, crossover study. Setting Pediatric Sedation Program Patients Children with acute leukemia or lymphoma receiving sedation for LP. Interventions Each patient received two sedations in random order, one with propofol/placebo and one with propofol/fentanyl. The study investigator and patient/parent were blinded to placebo or fentanyl. Data collected included patient age and diagnosis, propofol dose and adverse events. Adverse events included oxygen saturation < 94%, airway obstruction, apnea, hypotension and bradycardia (< 5% mean for age). Logistic regression analysis was utilized to assess probability of adverse events and the Wilcoxon Signed Rank and McNemar’s tests were used for paired comparisons. Measurements and Main Results Twenty-two patients were enrolled. Fourteen patients were male and 8 were female. Each patient was studied twice for a total of 44 sedations. The median age was 5.0 years (range 2.2–17.2 years). All procedures were successfully completed. The median total dose of propofol was 5.05 mg/kg (range 2.4–10.2 mg/kg) for propofol/placebo versus 3.00 mg/kg (range 1.4–10.5 mg/kg) for propofol/fentanyl (p < 0.001). Twelve adverse events occurred in 11 of 22 patients (50.0%) propofol/placebo compared to 6 of 22 (18.2%) propofol/fentanyl (p= 0.02). The most common adverse event was hypotension. Conclusions The combination of propofol and fentanyl versus propofol alone for LP sedation in children with acute hematologic malignancies resulted in lower propofol doses and fewer adverse events.
Propofol is a common sedative/anesthetic used for invasive procedures in children with cancer. The purpose of this study was to determine whether families of children with acute leukemia prefer propofol alone or propofol plus fentanyl for lumbar puncture (LP) sedation. We conducted a randomized, placebo controlled, double blind, crossover study. Each patient was studied twice, once with propofol/placebo and once with propofol/fentanyl. Data collected included the modified Yale Preoperative Anxiety Score (M-YPAS) at baseline and after placebo or fentanyl, Induction Compliance Checklist, recovery excitement, recovery time, and adverse events. After the study, families were asked which sedative regimen they preferred for future LPs. Twenty-two patients received 44 LP sedations: propofol 22, propofol/fentanyl 22. The average age was 6.4+/-4.2 years (mean+/-SD). There were no significant differences between groups in M-YPAS, Induction Compliance Checklist or recovery excitement. Adverse events occurred in 11/22 patients (50%) propofol and 4/22 (18.2%) propofol/fentanyl (P=0.0196). Average recovery time (mean+/-SD) was 36.86+/-17.1 minutes propofol versus 26.36+/-16.4 minutes propofol/fentanyl (P=0.047). Sixteen families (72.7%) chose propofol with fentanyl for future LP sedations (P=0.05). In conclusion, most families prefer propofol and fentanyl for LPs. Propofol with fentanyl was also associated with fewer adverse events and faster recovery.
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