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Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies

NCT02518919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-11-27

Study results available
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Summary

The role of Adjunct therapies such as Child Life therapy and Music listening during Procedural Sedation and Analgesia(PSA) for children during painful procedures has not been studied in the Emergency Department (ED). The investigators hypothesize that there will be a reduction in sedation medication dosage without change in sedation efficacy by addition of music therapy and Child Life to standard sedation protocol in children 3-15 years of age who undergo PSA for painful (orthopedic procedures, laceration repair, incision and drainage) procedures in a Pediatric emergency Department (PED).

Conditions

  • Conscious Sedation

Interventions

OTHER

Child life intervention

The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.

OTHER

Music listening

The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones

Sponsors & Collaborators

  • Children's Hospital of Michigan

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2016-10-18
Completion
2016-10-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02518919 on ClinicalTrials.gov