Continuous Infusion Versus Intermittent Boluses of Cisatracurium in the Early Management of Pediatric ARDS

Tanta University

Status and phase: Enrolling; Phase 4

Conditions: Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS); Respiratory Distress Syndrome, Pediatric

Treatments: Drug: Intermittent boluses of Cisatracurium; Drug: Intravenous infusion of Cisatracurium for 24 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT05153525

34409/1/21

Details and patient eligibility

About

The aim of this work is to compare continuous infusion vs on need intermittent boluses of Cisatracurium in the early management of pediatric acute respiratory distress syndrome

Full description

In the pediatric population, Acute respiratory distress syndrome (ARDS) has a high mortality rate of approximately 24%. In addition, there is a lack of high-quality data to guide the use of non-depolarizing neuromuscular blocking agents (NMBAs) in mechanically ventilated children. Hence, there is a need to evaluate its use in pediatrics.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children with mild, moderate, and severe ARDS diagnosed according to criteria of Pediatric Acute Lung Injury Consensus Conference (PALICC) in 2015.
2. Children of both sexes aged from one month to 18 years.
3. Children diagnosed with ARDS <48 hours before enrollment

Exclusion criteria

1. Continuous neuromuscular blockade at enrollment
2. Children on phenytoin and carbamazepine
3. Severe liver cirrhosis
4. High-risk medical illness (Bone marrow transplantation within the last one-year, Diffuse alveolar hemorrhage from vasculitis, Chronic respiratory failure, Burns > 70% total body surface)
5. Previous hypersensitivity or anaphylactic reaction to Cisatracurium
6. Neuromuscular conditions that may potentiate neuromuscular blockade and/or impair effective spontaneous ventilation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Intermittent boluses group

Experimental group

Description:

Thirty children with ARDS will be managed with intermittent boluses of Cisatracurium (0.1-0.15 mg/kg/dose).

Treatment:

Drug: Intermittent boluses of Cisatracurium

Intravenous infusion for 24 hours

Experimental group

Description:

Thirty children with ARDS will be treated with intravenous infusion of Cisatracurium titrated from 1 mic/kg/min till reaching the desired effect for 24 hours.

Treatment:

Drug: Intravenous infusion of Cisatracurium for 24 hours