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

NCT02518919 | Completed Results

• 1 other identifier: R1-2014-79
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Children; Emergency Department; Sedation

Outcome Measures

Primary Outcomes (1)

• Sedation Medication Requirement

  Total mg/kg of sedation medication administered IV

  Right at the end of the procedure

Secondary Outcomes (4)

• Sedation Efficacy

  During the Procedure

• Adverse Events

  during procedure until discharge from the Emergency Department

• Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"

  within two hours of completion of procedure

• Number of Participants Who Were re- Dosed With Sedation Medication

  during procedure

Study Arms (3)

Standard

NO INTERVENTION

Patients will receive intravenous ketamine (1-2mg/kg)

Child Life Intervention

EXPERIMENTAL

Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation

Other: Child life intervention

Music Listening

EXPERIMENTAL

Patients will listen to music of their choice using headphones during sedation

Other: Music listening

Interventions

Child life intervention OTHER

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.

Child Life Intervention

Music listening OTHER

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

Music Listening

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3-15 years
• American Society of Anesthesiologists (ASA) classification 1 or 2
• Receiving intravenous ketamine for PSA for painful procedures such as fracture/joint reduction, laceration repair, incision drainage of abscess .

You may not qualify if:

• Known contraindications, allergy or previous adverse events with ketamine
• Receive intramuscular or oral sedation or sedation medications other than ketamine
• Receive ketamine for procedures not listed above
• Outside the age range listed above
• Parents/guardians refuse study participation.

Sponsors & Collaborators

• Children's Hospital of Michigan: lead

Study Sites (1)

Children's Hospital of Michigan, Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (2)

• Lepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.

  PMID: 11574356 BACKGROUND

• Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. doi: 10.1097/00000542-199808000-00005.

  PMID: 9710387 BACKGROUND

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Study was a convenience sample. Small sample size. Study could not be blinded for obvious reasons. We did not study active music therapy but evaluated only music listening. We did not control for type of procedure.

Results Point of Contact

• Title: Dr. Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine
• Organization: Children's Hospital of Michigan

nkannike@dmc.org

313-745-5260

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics and Emergency Medicine

Study Record Dates

• First Submitted: August 3, 2015
• First Posted: August 10, 2015
• Study Start: October 1, 2015
• Primary Completion: October 18, 2016
• Study Completion: October 18, 2016
• Last Updated: November 27, 2018
• Results First Posted: November 1, 2018

Record last verified: 2018-10

Locations

US (1)