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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Music Listening | Experimental | Patients will listen to music of their choice using headphones during sedation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation Medication Requirement | Total mg/kg of sedation medication administered IV | Right at the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Michigan, Wayne State University | Detroit | Michigan | 48201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11574356 | Background | 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. | |
| 9710387 | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard | Patients will receive intravenous ketamine (1-2mg/kg) |
| FG001 | Music Listening | 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 |
| FG002 | Child Life Intervention | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard | Patients will receive intravenous ketamine (1-2mg/kg) |
| BG001 | Music Listening | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sedation Medication Requirement | Total mg/kg of sedation medication administered IV | Posted | Mean | Standard Deviation | mg/kg | Right at the end of the procedure |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard | Patients will receive intravenous ketamine (1-2mg/kg) | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Oxygen saturation of <90% |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nirupama Kannikeswaran, Associate Professor of Pediatrics and Emergency Medicine | Children's Hospital of Michigan | 313-745-5260 | nkannike@dmc.org |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
|
| During the Procedure |
| 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 |
| 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 |
| Number of Participants Who Were re- Dosed With Sedation Medication | compare the need for additional dosages of sedation medication among three groups | during procedure |
| BG002 | Child Life Intervention | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| American Society of Anesthesiologists(ASA) Classification | American Society of Anesthesiologists physical status classification is a system to assess fitness prior to surgery/procedure. ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation The addition of "E" denotes Emergency surgery Higher the ASA class higher the risk from sedation and procedure | Count of Participants | Participants |
|
| Procedure Type | Count of Participants | Participants |
|
| Pre - sedation pain medication | Count of Participants | Participants |
|
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. |
|
|
| 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.
| Posted | Median | Inter-Quartile Range | scores on a scale | During the Procedure |
|
|
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| Secondary | Adverse Events | describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 20 |
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | Music Listening | 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 | 0 | 20 | 0 | 20 | 8 | 20 |
| EG002 | Child Life Intervention | 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. | 0 | 19 | 0 | 19 | 5 | 19 |
|
| Emesis | Gastrointestinal disorders | Systematic Assessment | Vomiting |
|
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| Title | Measurements |
|---|---|
|
| Very Satisfied |
|