Abstract
BackgroundStress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients. Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives. Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy.The use of non-pharmacologic interventions has been recommended by sedation guidelines. However, non-pharmacological measures in PICU, including music and noise reduction, have been inadequately studied.MethodsThe Music Use for Sedation in Critically ill Children (MUSiCC trial) pilot study is an investigator-initiated, three-arm, randomized controlled trial (RCT) on the use of music for sedation in PICU. The main goal of the study is to demonstrate feasibility of a music trial in PICU and to obtain the necessary information to plan a larger trial. The study compares music versus noise cancelation versus control in sedated and mechanically ventilated children admitted to PICU. In the music group, children receive the music (modified classical music) three times a day for 30 min at a time. Music is delivered with noise cancelation headphones. The noise cancelation group receives the same intervention but with a no music (sham playlist). The control group receives usual care with no specific intervention. Children remain in the study until extubation or a maximum of 7 days. The primary outcomes of the study are feasibility and sedation/analgesia requirements. Secondary outcomes include change in vital signs before and during the intervention, ICU delirium, and adverse effects related to the intervention. The estimated sample size is 20 subjects per group for a total of 60 children.DiscussionDespite being recommended by current guidelines, evidence to support the use of music in PICU is lacking. Music has the potential to reduce sedation requirements and their negative side effects. This pilot RCT will demonstrate feasibility and provide the necessary information to plan a larger trial focusing on the effectiveness of the intervention.Trial registrationThe study was registered at ClinicalTrials.gov (NCT03497559) on April 13, 2018.
Highlights
Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the care to children as well as their recovery [1]
Study design The MUSiCC trial pilot study is an investigator-initiated, three-arm randomized controlled trial (RCT) examining the use of music for sedation in PICU
A parallel three-group design including a noise cancelation group was included based on adult data showing that noise cancelation can reduce sedation requirements as well as pediatric evidence that noise levels are associated with sedation requirements in Pediatric Cardiac Intensive Care Unit (PCICU) [13, 29]
Summary
Sedation/analgesia in PICU is usually achieved through various analgesics and sedatives Excessive use of these drugs can put patients at risk for hemodynamic/respiratory instability, prolonged ventilation, withdrawal, delirium, and critical illness polyneuromyopathy. Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the care to children as well as their recovery [1]. These negative consequences can lead to prolonged PICU stay and increase healthcare costs [2,3,4]
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