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

Phase 3

• Conditions: Congenital malformation of circulatory system, unspecified; C14.240.400

• Registration Number: RBR-10vtd55m
• Lead Sponsor: Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-01-01
• Study Start: 2022-12-29
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Parental request; intraoperative death; hemodynamic instability

Study & Design

• Study Type: Intervention
• Study Design: Not specified