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

Conscious Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518919
• Other study ID #: R1-2014-79
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: October 18, 2016

Study information

• Verified date: October 2018
• Source: Children's Hospital of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The investigators propose to perform a prospective randomized control trial on children aged 3-15 years of age who undergo PSA for painful procedures (orthopedic procedures, laceration repair, incision and drainage of abscess) at Children's Hospital of Michigan Emergency Department. The investigators will study the effect of child life specialist intervention and listening to music on the sedation medication requirement and sedation efficacy in those patients undergoing orthopedic procedures under PSA with intravenous ketamine Patients will be randomly allocated to one of the three groups: 1) Standard sedation protocol 2) standard sedation protocol with listening to music and 3) standard sedation protocol with child life intervention. This will be done by opening the double sealed envelope after obtaining informed consent from the parents/legal guardians. In addition, an assent will also be obtained from all children older than 7 years of age.

Study Intervention: Study population will be divided into 3 groups: 1) Standard sedation protocol 2) Standard sedation protocol with child life intervention and 3) Standard sedation protocol with music listening. All children enrolled in this study will receive sedation only after a pre sedation assessment has been performed using current institutional guidelines as has been applied to all ED sedation patients. Participants will be monitored using published sedation guidelines with measurements of vital signs, pulse oximetry at baseline, every 5 minutes during the procedure and post procedure for the entire duration of sedation. The dose of sedation medication administered will be at the discretion of the sedation physician and the study research assistant will not participate in any of the clinical procedures. For those participants assigned to the child life intervention group, trained child life personnel will introduce the procedure to the child and the family and will provide comforting measures appropriate to the age of the patient during the placement of intravenous line and throughout the procedure. The participants assigned to the music therapy group will be asked to choose a music of their choice which they will listen via head phones.

The investigators will collect the following variables: patient demographics, American Society of Anesthesiologists classification, indication for the sedation, sedation medication dosage, need for re-dosing, sedation related adverse events and ED disposition. In addition specifically for this study, the investigators will assess the pre-sedation agitation ,sedation efficacy using Ramsey Sedation Scale, pain scale using FACES-P and parent and consultant satisfaction using a 3-point Likert scale(very satisfied, satisfied, not satisfied). The Ramsey Sedation Scoring and FACES-P scoring will be performed by a trained research assistant who will be blinded to the sedation medication dosage at the following three time periods: just prior to administration of ketamine, during sedation and during recovery just prior to patient discharge.

In addition, the study research assistant will also complete a follow-up phone call within 72 hours after discharge from the ED to the parents/guardians of the children to evaluate for the particpant's experience with the sedation(the pain they perceived during the procedure, their memory of the event) and adverse events that occur at home.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: October 18, 2016
• Est. primary completion date: October 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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 .

Exclusion Criteria:

1. Known contraindications, allergy or previous adverse events with ketamine

2. Receive intramuscular or oral sedation or sedation medications other than ketamine

3. Receive ketamine for procedures not listed above

4. Outside the age range listed above

5. Parents/guardians refuse study participation.

Related Conditions & MeSH terms

• Conscious Sedation
• Emergencies

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan, Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

Koch ME, Kain ZN, Ayoub C, Rosenbaum SH. The sedative and analgesic sparing effect of music. Anesthesiology. 1998 Aug;89(2):300-6. — View Citation

Lepage C, Drolet P, Girard M, Grenier Y, DeGagné R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation Medication Requirement	Total mg/kg of sedation medication administered IV	Right at the end of the procedure
Secondary	Sedation Efficacy	compare sedation efficacy among the 3 groups using Ramsey sedation scales and FACES -P (FACES-Pediatric)scale. The Ramsey sedation scales scores sedation at six different levels, according to how arousable the patient is. The continuum of sedation is measured from 1-6 with higher values representing a deeper level of sedation.; Patient is anxious and agitated or restless, or both; Patient is co-operative, oriented, and tranquil; Patient responds to commands only; Patient exhibits brisk response to light glabellar tap or loud auditory stimulus; Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus; Patient exhibits no response The Faces- PScale is a self-report measure used to assess the intensity of children's pain. The scale ranges from 0 to 10 with 0 indicating no hurt or discomfort to 10 :hurts most/worst	During the Procedure
Secondary	Adverse Events	describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them	during procedure until discharge from the Emergency Department
Secondary	Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"	Compare consultant satisfaction among three groups using Likert scale	within two hours of completion of procedure
Secondary	Number of Participants Who Were re- Dosed With Sedation Medication	compare the need for additional dosages of sedation medication among three groups	during procedure