Caustic Esophageal Burns in Children and High Doses of Methylprednisolone

Sisli Hamidiye Etfal Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Esophageal Diseases

Treatments: Drug: methylprednisolon

Study type: Interventional

Funder types: Other

Identifiers

NCT02002078

ClinicalTrials.gov

Details and patient eligibility

About

Corrosive substance ingestion in childhood is a public health issue in developing countries and several management protocols were proposed to prevent esophageal strictures. The role of corticosteroids in preventing corrosive-induced strictures is controversial. The investigators' aim is to study the influence of high doses of corticosteroids to prevent esophageal strictures.

Enrollment: 83 patients

Sex: All

Ages: 12 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Corrosive substance ingested children with grade IIb esophageal burn

Exclusion criteria

• Caustic substance ingested chldren grade I, IIa and grade III esophageal burns
• Caustic subtance ingested children with signs of perforation, mediastinitis, peritonitis, sespis
• Caustic substance ingested children with any chronic disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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83 participants in 1 patient group

Methylprednisolone, caustic burns

No Intervention group

Treatment:

Drug: methylprednisolon