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

• ClinicalTrials.gov Identifier: NCT02518919
• Recruitment Status: Completed
• First Posted: August 10, 2015
• Results First Posted: November 1, 2018
• Last Update Posted: November 27, 2018
• Sponsor: Children's Hospital of Michigan
• Information provided by (Responsible Party): Nirupama Kannikeswaran, Children's Hospital of Michigan

Tracking Information

• First Submitted Date: August 3, 2015
• First Posted Date: August 10, 2015
• Results First Submitted Date: August 10, 2017
• Results First Posted Date: November 1, 2018
• Last Update Posted Date: November 27, 2018
• Actual Study Start Date: October 1, 2015
• Actual Primary Completion Date: October 18, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2018)

Sedation Medication Requirement [ Time Frame: Right at the end of the procedure ]

Total mg/kg of sedation medication administered IV

Original Primary Outcome Measures (submitted: August 7, 2015)

Sedation Medication Requirement [ Time Frame: one year ]

Total mg/kg of sedation medication administered IV

Current Secondary Outcome Measures (submitted: October 31, 2018)

• Sedation Efficacy [ Time Frame: 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.

  1. Patient is anxious and agitated or restless, or both
  2. Patient is co-operative, oriented, and tranquil
  3. Patient responds to commands only
  4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus
  5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
  6. 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
• Adverse Events [ Time Frame: 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
• Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied," [ Time Frame: within two hours of completion of procedure ]
  Compare consultant satisfaction among three groups using Likert scale
• Number of Participants Who Were re- Dosed With Sedation Medication [ Time Frame: during procedure ]
  compare the need for additional dosages of sedation medication among three groups

Original Secondary Outcome Measures (submitted: August 7, 2015)

• Sedation Efficacy [ Time Frame: one year ]
  compare sedation efficacy among the 3 groups using Ramsey sedation scales and FACES -P scale.
• Adverse Events [ Time Frame: one year ]
  describe the adverse events experienced by study participants secondary to sedation medication and interventions performed to overcome them
• Consultant satisfaction [ Time Frame: one year ]
  Compare consultant satisfaction among three groups using Likert scale
• Sedation Duration [ Time Frame: one year ]
  Compare sedation duration among three groups. Sedation duration is defined as the duration from time of administration of sedation medication until ready for discharge using Aldrete score>9
• Re dosing [ Time Frame: one year ]
  compare the need for additional dosages of sedation medication among three groups

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Conscious Sedation

Intervention

• 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.
• 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

Study Arms

• 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
  Intervention: Other: Child life intervention
• Experimental: Music Listening
  Patients will listen to music of their choice using headphones during sedation
  Intervention: Other: Music listening

Publications *

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2017): 63
• Original Estimated Enrollment (submitted: August 7, 2015): 75
• Actual Study Completion Date: October 18, 2016
• Actual Primary Completion Date: October 18, 2016 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Years to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02518919
• Other Study ID Numbers: R1-2014-79
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nirupama Kannikeswaran, Children's Hospital of Michigan
• Study Sponsor: Children's Hospital of Michigan
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Children's Hospital of Michigan
• Verification Date: October 2018