N/A
N=63
Procedural Sedation And Analgesia in Children in the Emergency Department: The Role of Adjunct Therapies
Conscious Sedation
Bottom Line
View on ClinicalTrials.gov: NCT02518919 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Sedation Medication Requirement — 1.58; 1.68; 1.42 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Child life intervention (Other); Music listening (Other)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Michigan
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sedation Medication Requirement |
1.58; 1.68; 1.42 | — |
| SECONDARY Sedation Efficacy |
6; 6; 6; 0; 0; 0 | — |
| SECONDARY Adverse Events |
4; 8; 5 | — |
| SECONDARY Number of Participants With Consultant Satisfaction Rating as Either" Not Satisfied", "Satisfied", or "Very Satisfied," |
0; 0; 0; 13; 8; 6 | — |
| SECONDARY Number of Participants Who Were re- Dosed With Sedation Medication |
9; 4; 8 | — |
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).
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
- Known contraindications, allergy or previous adverse events with ketamine
- Receive intramuscular or oral sedation or sedation medications other than ketamine
- Receive ketamine for procedures not listed above
- Outside the age range listed above
- Parents/guardians refuse study participation.
Data sourced from ClinicalTrials.gov (NCT02518919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.