Clinical Trial
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Use of ketofol for procedural sedation and analgesia in children with hematological diseases.

BACKGROUND: The aim of this study was to evaluate the effectiveness and safety of intravenous ketamine-propofol admixture ("ketofol") in the same syringe for procedural sedation and analgesia in children undergoing bone marrow aspiration.

METHODS: This was a prospective, observational pilot study. Patients aged between 4 and 12 years requiring sedation for bone marrow aspiration were included. Ketofol (1:1 mixture of ketamine 10 mg/mL and propofol 10 mg/mL) was given intravenously in 0.5 mg/kg aliquots each with a 1-min interval and titrated to reach sedation levels of 3 or 4 (Ramsay score). The primary outcome was patient satisfaction with the degree of sedation. Secondary outcomes included injection pain, total sedation time, recovery time, hemodynamic and respiratory parameters, and adverse events.

RESULTS: A total of 20 patients were enrolled in the study. The median total dose of ketofol administered was 1.25 mg/kg each of propofol and ketamine (95%CI 0.77-2 mg/kg). The median score on the visual analog scale was 0 (extremely comfortable) (0-1.5; 95%CI 0.2-2.2). Median recovery time was 23 min (20.5-28 min; 95%CI 17.1-51.2). The incidence of injection pain was 2/20. Two patients had transient diplopia and one child reported dreams. No patients had hypotension, vomiting or required airway intervention.

CONCLUSION: Ketofol provided effective sedation, which was reflected in the high degree of satisfaction recorded by children requiring procedural sedation and analgesia for bone marrow aspiration. We also observed rapid recovery and no clinically significant complications. A large number of patients is required to evaluate and validate these findings.

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