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Research purposes:Comparison of preoperative folic acid and placebo intervention on postoperative recovery of sputum in children undergoing general anesthesia for head and neck and maxillofacial surgery Test type:Randomized, double-blind, placebo-controlled, prospective study Randomized grouping: Patients were randomized into an intervention group (fed for 7 days before surgery) and a placebo group (7 days for placebo) Test subjects: recruitment and sample size calculation, inclusion criteria, exclusion criteria, shedding cases, trial suspension, rejection criteria, trial termination,Test contents Evaluation indicators: main observation indicators, secondary observation indicators Adverse events: definition of adverse events, recording of adverse events, treatment of adverse events, assessment of adverse events, serious adverse events, definition of serious adverse events, recording and reporting of serious adverse events
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According to literature review, the incidence of sputum sputum in children is about 38.8% (Reference 1), and the incidence of sputum sputum in the placebo group is 38%, assuming a class of error probability α = 0.05, test efficiency 1-β=0.8, considering folic acid supplementation for 7 days can reduce the incidence of sputum to 23%. A chi-square test is proposed to assess whether there is a difference in the incidence of sputum between groups. Calculated by PASS software, the sample size was 300. Considering the 5% drop rate, a total of 316 inpatients with head and neck and maxillofacial surgery were included, divided into 2 groups, 158 cases in each group.
The PAED score was scored every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation (total score 0-20, score ≥10 is defined as the recovery period).
8.2 secondary observation indicators:
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300 participants in 2 patient groups
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lei zhang, Doctor
Data sourced from clinicaltrials.gov
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