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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-10vtd55m
Enrollment
Unknown
Registered
2022-12-29
Start date
2018-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital malformation of circulatory system, unspecified

Interventions

This is a double-blind, randomized, placebo-controlled trial at a pediatric intensive care unit in a Brazilian tertiary-care university hospital. The randomization will be in blocks of random size (4

Sponsors

Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Lead Sponsor
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Collaborator

Eligibility

Age
No minimum to 18 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Parental request; intraoperative death; hemodynamic instability

Design outcomes

Primary

MeasureTime frame
Expected outcome 2: We expect to find a decrease in pain caused by lidocaine, assessed by the face, legs, activity, cry, consolability pain scale – revised (FLACC-R);Observed outcome 2: We did not find a decrease in pain caused by lidocaine, assessed by the face, legs, activity, cry, consolability pain scale – revised (FLACC-R)

Secondary

MeasureTime frame
Expected outcome 1: We expect to find an increase in pain caused by respiratory therapy, assessed by the face, legs, activity, cry, consolability pain scale – revised (FLACC-R);Observed outcome 1: We did not find an increase in pain caused by respiratory therapy, assessed by the face, legs, activity, cry, consolability pain scale – revised (FLACC-R)

Countries

Brazil

Contacts

Public ContactFabio Carmona

Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

carmona@fmrp.usp.br+551636022477

Outcome results

None listed

Source: REBEC (via WHO ICTRP)