Music Use for Sedation In Critically Ill Children

Summary

Stress induced by pain and anxiety is common in pediatric intensive care unit (PICU) patients and can impede the delivery of care as well as their recovery. Sedation/analgesia in PICU is usually achieved using narcotics and benzodiazepines. Excessive use of these drugs can put patients at risk for hemodynamic and respiratory instability, prolonged mechanical ventilation, withdrawal symptoms, and delirium. Non-pharmacologic measures for analgesia and anxiolysis may reduce the total medication requirement and their side effects. The use of non-pharmacologic interventions, including music, has been recommended by sedation guidelines for critically ill patients; however, it is not clear how these interventions should be provided. We plan to conduct a pilot 3-arm RCT to determine the feasibility of a music intervention and assess its effects on sedation/analgesia requirements in children admitted to PICU. Children will be randomly assigned to receive music, noise cancellation or control. Music will be delivered by headphones and an iPod. Music will consist on classical music selected by the study's pediatric music therapist. The noise cancellation group will receive the same headphones but without music. Clinical care of the participants, including use of sedation and analgesia drugs, will not be protocolized. Primary outcomes of this pilot trial is feasibility. Secondary outcomes are drug requirements for sedation and analgesia, and incidence of delirium. These requirements will be captured as a daily intensity score and intermittent dose (PRN) frequency. Mixed-effects models will be used to analyze the effect of the music on sedation/analgesia requirements.

Conditions

• Music Therapy
• Critical Care
• Analgesia
• Ventilators, Mechanical

Interventions

OTHER

Music

Classical music

Sponsors & Collaborators

• Women and Children's Health Research Institute, Canada

  collaborator OTHER

• World Federation of Pediatric Intensive and Critical Care Societies

  collaborator UNKNOWN

• University of Alberta

  lead OTHER

Principal Investigators

• Gonzalo Garcia Guerra, MD, MSc · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Month

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-30

Primary Completion

2019-04-11

Completion

2019-04-30

Countries

• Canada

Study Locations