Prospective Randomized Crossover Evaluation of Three Anesthetic Regimens for Painful Procedures in Children with Cancer

Abstract

To identify the most effective sedation regimen for bone marrow aspiration and lumbar puncture procedures with a prospective trial of 3 combinations of sedation/analgesia. In this double-blind crossover study, we randomly assigned 162 children with acute lymphoblastic leukemia or lymphoblastic lymphoma to receive fentanyl 1 mcg/kg, fentanyl 0.5 mcg/kg, or placebo, in addition to propofol and topical anesthetic for 355 procedures. We found no significant differences among the 3 regimens in the frequency of pain (pain score > 0) or severe pain (pain score ≥ 5) during recovery, or a >20% increase in hemodynamic/respiratory variables during anesthesia. Treatment with fentanyl 1 mcg/kg was associated with a lower frequency of movement during procedure compared with treatment with fentanyl 0.5 mcg/kg (P = .0476) or treatment with placebo (P = .0545). The placebo group required longer time to recover (median, 18 minutes) compared with the fentanyl 0.5 mcg/kg group (median, 9 minutes) (median difference 2.0, P = .007) and the fentanyl 1 mcg/kg (median 8 minutes), (median difference 2.0, P = .15). The placebo group also required larger total dose of propofol (median 5 mg/kg) compared with that of the fentanyl 1 mcg/kg group (median, 3.5 mg/kg) and the fentanyl 0.5 mcg/kg group (median 3.5 mg/kg) (median differences 1.5, P < .00005, in both comparisons). The addition of fentanyl 1 mcg/kg to propofol for brief painful procedures reduces movement, propofol dose, and recovery time.