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临床试验/RBR-10vtd55m
RBR-10vtd55m已完成3 期

Assessment of pain caused by respiratory therapy in children with congenital heart disease after surgery

Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo0 个研究点开始时间: 2022年12月29日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方

研究概览

简要总结

Objective: To investigate whether respiratory therapy (RT) increases pain and whether inhaled lidocaine can attenuate pain increase in infants and children undergoing surgery for congenital heart disease (CHD). Method: Double-blind, randomized, placebo-controlled trial at a pediatric intensive care unit in a Brazilian tertiary-care university hospital. Patients < 18 years submitted to open-heart surgery for CHD were included and randomized to receive either aerosolized lidocaine (1 mg/kg) or placebo before RT maneuvers and tracheal suction. Pain was assessed by the face, legs, activity, cry, consolability pain scale – revised (FLACC-R), along with hemodynamic and ventilatory parameters, before and after RT on postoperative days 1, 3, and 7. Results: 119 patients were included. RT induced minor changes in pain, which were not attenuated by lidocaine (confirmed in multivariate analysis). RT also caused minor, clinically not relevant effects in hemodynamic and ventilatory parameters, which were also not modified by lidocaine. Conclusions: Respiratory therapy did not increase postoperative pain in patients after pediatric congenital heart surgery until the 7th day, nor did aerosolized lidocaine exhibit any clinically significant effect on pain or other hemodynamic or ventilatory parameters.

研究设计

研究类型
Intervention

入排标准

年龄范围
0 至 18Y(—)

入选标准

  • Children with congenital heart disease; both genders; age between 0 and 18 years; undergoing heart surgery

排除标准

  • Parental request; intraoperative death; hemodynamic instability

研究者

发起方
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

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