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 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 lumbar puncture. 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 used 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 eight were female. Each patient was studied twice for a total of 44 sedations. The median age was 5.0 yrs (range, 2.2-17.2 yrs). 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 vs. 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 with 6 of 22 (18.2%) propofol/fentanyl (p = 0.02). The most common adverse event was hypotension. CONCLUSIONS: The combination of propofol and fentanyl vs. propofol alone for lumbar puncture sedation in children with acute hematologic malignancies resulted in lower propofol doses and fewer adverse events.
RCT Entities:
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 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 lumbar puncture. 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 used 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 eight were female. Each patient was studied twice for a total of 44 sedations. The median age was 5.0 yrs (range, 2.2-17.2 yrs). 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 vs. 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 with 6 of 22 (18.2%) propofol/fentanyl (p = 0.02). The most common adverse event was hypotension. CONCLUSIONS: The combination of propofol and fentanyl vs. propofol alone for lumbar puncture sedation in children with acute hematologic malignancies resulted in lower propofol doses and fewer adverse events.
Authors: Scott M Klein; Gabriel J Hauser; Barry D Anderson; Aziza T Shad; Joseph E Gootenberg; Heidi J Dalton; James H Hertzog Journal: Pediatr Crit Care Med Date: 2003-01 Impact factor: 3.624
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