Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
Condition: Conscious Sedation
MeSH terms: Emergencies
Study type: Interventional

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.
    

Intervention name(s): Child life intervention; Music listening
Intervention type(s): Other; Other
Intervention description(s): 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.; The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Children; Emergency Department; Sedation