Clinical trial NCT02518919: Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
Official title: Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation
Keywords: Children
Emergency Department
Sedation
Lead sponsor: Children's Hospital of Michigan
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 63
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sedation Medication Requirement
timeFrame: Right at the end of the procedure
Secondary outcomes:
measure: Sedation Efficacy
timeFrame: During the Procedure
measure: Adverse Events
timeFrame: during procedure until discharge from the Emergency Department
measure: Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied,"
timeFrame: within two hours of completion of procedure
measure: Number of Participants Who Were re- Dosed With Sedation Medication
timeFrame: during procedure
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Children's Hospital of Michigan, Wayne State University
state: Michigan
Study officials:
References:
citation: 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.
citation: 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.