Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 3 - 15 |
| Updated: | 11/29/2018 |
| Start Date: | October 1, 2015 |
| End Date: | October 18, 2016 |
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).
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.
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.
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.
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