Prospective randomized controlled trial on the application of sevoflurane inhalation sedation and analgesia during dressing changes in children with extensive burns
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摘要:
目的 探讨七氟醚吸入镇静镇痛应用于大面积烧伤患儿换药的安全性以及有效性。 方法 采用前瞻性随机对照研究方法。2020年3月—2023年1月，昆明市儿童医院烧伤整形外科收治216例符合入选标准的大面积烧伤患儿。采用随机数字表法将患儿分为七氟醚组和布洛芬组，剔除脱落患儿后，七氟醚组中最终纳入103例患儿，其中男67例、女36例，年龄1（1，2）岁；布洛芬组最终纳入98例患儿，其中男67例、女31例，年龄1（1，2）岁。七氟醚组患儿换药时吸入七氟醚镇静镇痛，布洛芬组患儿换药前口服布洛芬镇痛。监测并记录患儿换药开始前30 min，清创后即刻、换药完毕后30 min的心率、平均动脉压（MAP）、经皮动脉血氧饱和度（SpO 2）；分别采用面部表情、腿部动作、活动度、哭闹和可安慰性量表和Ramsay镇静量表评估患儿换药开始前30 min、清创后即刻、换药完毕后30 min的疼痛强度及镇静程度；记录换药时间与住院期间总换药次数；在患儿出院时，采用休斯敦疼痛情况调查表调查换药医师及1名患儿家属对患儿换药过程中镇痛效果的满意度；监测记录患儿换药过程中发生的呼吸抑制、低氧血症等不良反应。对数据行独立样本 t检验、重复测量方差分析、Wilcoxon秩和检验、 χ 2检验、Fisher确切概率法检验。 结果 换药开始前30 min和换药完毕后30 min，2组患儿心率、MAP、SpO 2比较，差异均无统计学意义（ P>0.05）。清创后即刻，与布洛芬组比较，七氟醚组患儿心率、MAP均明显降低（ t值分别为8.10、4.37， P<0.05），而SpO 2明显升高（ t=21.77， P<0.05）。换药开始前30 min和换药完毕后30 min，2组患儿疼痛强度评分、镇静程度评分比较，差异均无统计学意义（ P>0.05）。清创后即刻，与布洛芬组比较，七氟醚组患儿疼痛强度评分明显降低，而镇静程度评分明显升高（ t值分别为42.87、72.45， P<0.05）。七氟醚组患儿的换药时间、住院期间总换药次数分别为（18±3）min、（4.1±1.0）次，分别明显短于、少于布洛芬组的（26±7）min、（6.6±1.4）次（ t值分别为-4.44、14.17， P<0.05）。出院时，七氟醚组患儿的换药医师和家属对换药过程中的镇痛效果满意度评分均明显高于布洛芬组（ t值分别为44.23、36.55， P<0.05）。2组患儿换药过程中呼吸抑制、低氧血症、低血压、呛咳、恶心呕吐发生率比较，差异均无统计学意义（ P>0.05）。 结论 将七氟醚吸入用于大面积烧伤患儿换药，能安全、有效控制疼痛及镇静，缩短换药时间，不良反应少，该方法可用于儿童烧伤病房日常换药。 Abstract:Objective To explore the safety and effectiveness of the application of sevoflurane inhalation sedation and analgesia during dressing changes in children with extensive burns. Methods A prospective randomized controlled research was conducted. From March 2020 to January 2023, 216 children with extensive burns who met the inclusion criteria were admitted to the Department of Burns and Plastic Surgery of Kunming Children's Hospital. According to the random number table, the children were divided into sevoflurane group and ibuprofen group, with 103 cases left in sevoflurane group (67 males and 36 females, aged 1 (1, 2) years), and 98 cases left in ibuprofen group (67 males and 31 females, aged 1 (1, 2) years) after the exclusion of several dropped-out children. Children in sevoflurane group received sevoflurane inhalation for sedation and analgesia during dressing changes, while those in ibuprofen group took oral ibuprofen for analgesia before dressing changes. The heart rate, mean arterial pressure (MAP), and percutaneous arterial oxygen saturation (SpO 2) of the children were monitored and recorded at 30 minutes before the start of dressing changes, immediately after debridement, and at 30 minutes after the completion of dressing changes. The face, legs, activity, cry, and consolability scale and Ramsay sedation scale were used to evaluate the pain intensity and degree of sedation, respectively, at 30 minutes before the start of dressing changes, immediately after debridement, and at 30 minutes after the completion of dressing changes. The duration of dressing changes and the total number of dressing changes during hospitalization were recorded. The Houston Pain Outcome Instrument questionnaire was used to assess the satisfaction of the dressing-changing surgeons and a family member of the child with the analgesic effects during the process of dressing change when the children were discharged from the hospital. The occurrence of adverse reactions such as respiratory depression and hypoxemia that occurred during the process of dressing change were monitored and recorded. Data were statistically analyzed with independent sample t test, analysis of variance for repeated measurement, Wilcoxon rank-sum test, chi-square test, and Fisher's exact probability test. Results At 30 minutes before the start of dressing changes and 30 minutes after the completion of dressing changes, there were no statistically significant differences in heart rate, MAP, and SpO 2 between children in the two groups ( P>0.05). Immediately after debridement, compared with those in ibuprofen group, the heart rate and MAP of children in sevoflurane group were significantly decreased (with t values of 8.10 and 4.37, respectively, P<0.05), while the SpO 2 was significantly increased ( t=21.77, P<0.05). At 30 minutes before the start of dressing changes and 30 minutes after the completion of dressing changes, there were no statistically significant differences in the score of pain intensity and score of sedation degree between children in the two groups ( P>0.05). Immediately after debridement, compared with that in ibuprofen group, the score of pain intensity of children in sevoflurane group was significantly decreased, while the score of sedation degree was significantly increased (with t values of 42.87 and 72.45, respectively, P<0.05). The duration of dressing changes and the total number of dressing changes during hospitalization of patients in sevoflurane group were (18±3) min and (4.1±1.0) times, respectively, which were both significantly shorter than (26±7) min and less than (6.6±1.4) times in ibuprofen group, respectively (with t values of -4.44 and 14.17, respectively, P<0.05). Upon discharge, the satisfaction scores of dressing-changing surgeons and the family members of children with the analgesic effects during the process of dressing change in sevoflurane group were significantly higher than those in ibuprofen group (with t values of 44.23 and 36.55, respectively, P<0.05). There were no statistically significant differences in the incidence of respiratory depression, hypoxemia, hypotension, coughing, nausea, and vomiting during the process of dressing change between children in the two groups ( P>0.05). Conclusions Application of sevoflurane inhalation during dressing changes in children with extensive burns can safely and effectively control pain and sedation, shorten the time for dressing change, with fewer adverse reactions. This method can be used for routine dressing change in pediatric burn wards. -
Key words:
- Burns /
- Child /
- Pain /
- Deep sedation /
- Analgesia
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参考文献
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表1 2组大面积烧伤患儿临床资料比较
表1. Comparison of clinical data between two groups of children with extensive burns
组别 例数 性别（例） 年龄［岁， M（ Q 1， Q 3）］ 体重（kg， 烧伤总面积 （%TBSA， 深Ⅱ度烧伤面积（%TBSA， 伤后入院时间［h ， M（ Q 1， Q 3）］换药部位（例） 男 女 多部位 单纯 躯干 单纯 四肢 单纯头面颈 七氟醚组 103 67 36 1（1，2） 13±3 15±4 6.2±1.3 6（4，9） 62 12 22 7 布洛芬组 98 67 31 1（1，2） 13±3 16±5 7.2±0.5 6（4，9） 63 7 24 4 统计量值 χ 2=0.50 Z=1.68 t=0.83 t=1.31 t=-0.14 Z=-0.13 χ 2=2.10 P值 0.618 0.940 0.407 0.192 0.812 0.901 0.550 注：TBSA为体表总面积 
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表2 2组大面积烧伤患儿各时间点生命体征比较（
表2. Comparison of vital signs at different time points between two groups of children with extensive burns
组别与时间点 例数 心率（次/min） MAP （ mmHg）SpO 2 七氟醚组 103 换药开始前30 min 112±13 53±5 0.994 4±0.007 2 清创后即刻 119±15 55±6 0.981 6±0.004 1 换药完毕后30 min 115±17 54±5 0.982 1±0.009 2 布洛芬组 98 换药开始前30 min 113±11 54±5 0.982 4±0.001 3 清创后即刻 138±11 59±6 0.953 9±0.035 4 换药完毕后30 min 115±13 56±6 0.983 0±0.003 3 t 1值 0.38 0.63 0.37 P 1值 0.705 0.984 0.714 t 2值 8.10 4.37 21.77 P 2值 <0.001 <0.001 <0.001 t 3值 0.44 1.78 1.11 P 3值 0.657 0.530 0.268 注：MAP为平均动脉压，SpO 2为经皮动脉血氧饱和度；1 mmHg=0.133 kPa；心率处理因素主效应， F=26.54， P<0.001；时间因素主效应， F=29.71， P<0.001；两者交互作用， F=19.72， P<0.001；MAP处理因素主效应， F=9.63， P=0.002；时间因素主效应， F=15.34， P<0.001；两者交互作用， F=6.33， P=0.002；SpO 2处理因素主效应， F=180.13， P<0.001；时间因素主效应， F=145.44， P<0.001；两者交互作用， F=147.22， P<0.001； t 1值、 P 1值， t 2值、 P 2值， t 3值、 P 3值分别为组间换药开始前30 min、清创后即刻、换药完毕后30 min各指标比较所得
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表3 2组大面积烧伤患儿各时间点疼痛强度评分及镇静程度评分比较（分，
表3. Comparison of scores of pain intensity and scores of sedation degree at different time points between two groups of children with extensive burns
组别与时间点 例数 疼痛强度评分 镇静程度评分 七氟醚组 103 换药开始前30 min 3.02±0.92 2.09±0.28 清创后即刻 0.54±0.17 5.85±0.59 换药完毕后30 min 2.67±0.84 2.15±0.83 布洛芬组 98 换药开始前30 min 2.95±0.83 2.01±0.32 清创后即刻 6.49±1.93 1.06±0.24 换药完毕后30 min 2.75±0.60 2.14±0.71 t 1值 0.34 0.33 P 1值 0.981 0.983 t 2值 42.87 72.45 P 2值 <0.001 <0.001 t 3值 0.50 0.50 P 3 值 0.944 0.872 注：疼痛强度评分处理因素主效应， F=6.17， P<0.001；时间因素主效应， F=17.52， P<0.001；两者交互作用， F=6.11， P<0.001；镇静程度评分处理因素主效应， F=3.31， P<0.001；时间因素主效应， F=1.30， P<0.001；两者交互作用， F=13.48， P<0.001； t 1值、 P 1值, t 2值、 P 2值， t 3值、 P 3值分别为组间换药开始前30 min、清创后即刻、换药完毕后30 min各指标比较所得
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表4 出院时2组大面积烧伤患儿的换药医师和家属对换药过程中的镇痛效果满意度评分比较（分，
表4. Comparison of satisfaction scores of the dressing-changing surgeons and family members of the children with the analgesic effects during the process of dressing change at the discharge
组别 例数 换药医师 家属 七氟醚组 103 9.5±0.7 9.1±0.9 布洛芬组 98 2.4±1.5 3.2±1.3 t值 44.23 36.55 P值 <0.001 <0.001
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表5 2组大面积烧伤患儿换药过程中不良反应发生情况比较[例（%）]
表5. Comparison of occurrence of adverse reactions during the process of dressing change between two groups of children with extensive burns
组别 例数 呼吸抑制 低氧血症 低血压 呛咳 恶心呕吐 七氟醚组 103 2（1.9） 2（1.9） 2（1.9） 3（2.9） 2（1.9） 布洛芬组 98 0 7（7.1） 5（5.1） 5（5.1） 7（7.1） P值 0.504 0.094 0.273 0.492 0.091
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