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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention group: patients took 7 days of folic acid tablets before surgery (0.3mg/d for children aged 1-3, 0.4mg/d for children aged 4~5 years, dissolved in 20ml brown sugar water.) |
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| Placebo group | Experimental | Placebo group: The patient received the same dose of brown sugar water for 7 days before surgery. Folic acid dose selection is based on the maximum daily intake of children(tolerable upper intake levels,UL) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid | Drug | The patient was continuously taking 7 ml of a brown sugar aqueous solution containing a certain amount of folic acid for 7 days before surgery (0.3 mg/d for children with 1-3 years old and 0.4 mg/d for children aged 4 to 5, once a day). After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0~20 points, and the score ≥10 points is defined as the recovery period). |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of sputum in children | The incidence of sputum in children with major indicators was tested by chi-square test or exact probability method. | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| lei zhang, Doctor | Contact | 18717822662 | weiymzhl@126.com |
| Name | Affiliation | Role |
|---|---|---|
| ren zhou, Doctor | shanghai Ninth People Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15114210 | Background | Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015. |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebos | Drug | Patients in the placebo group received 20 ml of an aqueous solution of brown sugar with the same concentration as the intervention group on the 7th day before surgery. After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0~20 points, and the score ≥10 points is defined as the recovery period). |
|
| D006571 | Heterocyclic Compounds |