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

• Sponsor: Children's Hospital of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT02518919
• Collaborator: (none)
• Enrollment: 63
• Location: 1
• Arms: 3
• Actual Duration (Months): 12.6
• Patients Per Site Per Month: 5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Conscious Sedation	Other: Child life intervention; Other: Music listening	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Oct 18, 2016
• Actual Study Completion Date: Oct 18, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Patients will receive intravenous ketamine (1-2mg/kg)
Experimental: Child Life Intervention Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation	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.
Experimental: Music Listening Patients will listen to music of their choice using headphones during sedation	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

Outcome Measures

Primary Outcome Measures

1. Sedation Medication Requirement [Right at the end of the procedure]

   Total mg/kg of sedation medication administered IV

Secondary Outcome Measures

1. Sedation Efficacy [During the Procedure]

   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

2. Adverse Events [during procedure until discharge from the Emergency Department]

   describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them

3. Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied," [within two hours of completion of procedure]

   Compare consultant satisfaction among three groups using Likert scale

4. Number of Participants Who Were re- Dosed With Sedation Medication [during procedure]

   compare the need for additional dosages of sedation medication among three groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Michigan, Wayne State University	Detroit	Michigan	United States	48201

Sponsors and Collaborators

• Children's Hospital of Michigan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine, Children's Hospital of Michigan
• ClinicalTrials.gov Identifier: NCT02518919
• Other Study ID Numbers: R1-2014-79
• First Posted: Aug 10, 2015
• Last Update Posted: Nov 27, 2018
• Last Verified: Oct 1, 2018

• Keywords provided by Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine, Children's Hospital of Michigan: Children; Emergency Department; Sedation
• Additional relevant MeSH terms: Emergencies

Study Results

Participant Flow

Pre-assignment Detail	Patients were screened for eligibility using electronic medical records and if eligible were approached by the study Research Assistant(RA) for informed consent. If the parent/guardian refused participation, were non- English speaking and if parent/legal guardian was not present to complete the informed consent process they were excluded from study

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Period Title: Overall Study
STARTED	21	21	21
COMPLETED	20	20	19
NOT COMPLETED	1	1	2

Baseline Characteristics

Arm/Group Title	Standard	Music Listening	Child Life Intervention	Total
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.	Total of all reporting groups
Overall Participants	20	20	19	59
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	5	8.5	9	8
Sex: Female, Male (Count of Participants)
Female	8 40%	6 30%	13 68.4%	27 45.8%
Male	12 60%	14 70%	6 31.6%	32 54.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 10%	0 0%	2 10.5%	4 6.8%
Not Hispanic or Latino	18 90%	20 100%	17 89.5%	55 93.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 10%	1 5%	3 15.8%	6 10.2%
Caucasian	4 20%	9 45%	3 15.8%	16 27.1%
African American	12 60%	9 45%	10 52.6%	31 52.5%
Mixed	0 0%	1 5%	0 0%	1 1.7%
Others	2 10%	0 0%	3 15.8%	5 8.5%
American Society of Anesthesiologists(ASA) Classification (Count of Participants)
American Society of Anesthesiologist, ASA I	16 80%	15 75%	16 84.2%	47 79.7%
American Society of Anesethesiologist, ASA II	4 20%	5 25%	3 15.8%	12 20.3%
Procedure Type (Count of Participants)
fracture/dislocation reduction	12 60%	16 80%	13 68.4%	41 69.5%
Incision and drainage	1 5%	1 5%	2 10.5%	4 6.8%
laceration repair	7 35%	3 15%	4 21.1%	14 23.7%
Pre - sedation pain medication (Count of Participants)
Pre sedation pain medication yes	14 70%	10 50%	14 73.7%	38 64.4%
Pre sedation pain medication no	6 30%	10 50%	5 26.3%	21 35.6%

Outcome Measures

1. Primary Outcome

Title	Sedation Medication Requirement
Description	Total mg/kg of sedation medication administered IV
Time Frame	Right at the end of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Measure Participants	20	20	19
Mean (Standard Deviation) [mg/kg]	1.58 (0.44)	1.68 (0.36)	1.42 (0.47)

2. Secondary Outcome

Title	Sedation Efficacy
Description	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
Time Frame	During the Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Measure Participants	20	20	19
Ramsay Sedation Score during sedation	6	6	6
FACES-Pediatric during sedation	0	0	0

3. Secondary Outcome

Title	Adverse Events
Description	describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them
Time Frame	during procedure until discharge from the Emergency Department

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Measure Participants	20	20	19
Count of Participants [Participants]	4 20%	8 40%	5 26.3%

4. Secondary Outcome

Title	Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"
Description	Compare consultant satisfaction among three groups using Likert scale
Time Frame	within two hours of completion of procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Measure Participants	20	20	19
Not satisfied	0 0%	0 0%	0 0%
Satisfied	13 65%	8 40%	6 31.6%
Very Satisfied	7 35%	12 60%	13 68.4%

5. Secondary Outcome

Title	Number of Participants Who Were re- Dosed With Sedation Medication
Description	compare the need for additional dosages of sedation medication among three groups
Time Frame	during procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Music Listening	Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)	Patients will listen to music of their choice using headphones during sedation 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	Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
Measure Participants	20	20	19
Count of Participants [Participants]	9 45%	4 20%	8 42.1%

Adverse Events

Arm/Group Title	Standard		Music Listening		Child Life Intervention
Arm/Group Description	Patients will receive intravenous ketamine (1-2mg/kg)		Patients will listen to music of their choice using headphones during sedation 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		Child life therapist will comfort the child during all painful procedures(including IV insertion) and during sedation 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.
All Cause Mortality
	Standard		Music Listening		Child Life Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/19 (0%)
Serious Adverse Events
	Standard		Music Listening		Child Life Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Standard		Music Listening		Child Life Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/20 (20%)		8/20 (40%)		5/19 (26.3%)
Gastrointestinal disorders
Emesis	3/20 (15%)	3	8/20 (40%)	8	3/19 (15.8%)	3
Respiratory, thoracic and mediastinal disorders
Oxygen desaturation	1/20 (5%)	1	0/20 (0%)	0	2/19 (10.5%)	2

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.