N/A
N=40
Jackson Pediatric Acupressure for Opioid Tapering
Iatrogenic Withdrawal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05025384 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) — 3.0; 3.0 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupressure (Other)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) |
3.0; 3.0 | — |
| PRIMARY Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU) |
2.0; 2.0 | — |
| PRIMARY Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS) |
-0.3; 0 | — |
Summary
This intervention pilot feasibility study will assess the impact of auricular acupressure as an additional non-pharmacologic therapy for infants at risk for developing Iatrogenic Withdrawal Syndrome (IWS) in the Pediatric Cardiac Intensive Care Unit (PCICU) of Monroe Carrell Jr Children's Hospital at Vanderbilt (MCJCHV). The investigators will recruit 40 healthy, 34 weeks gestational age or older infants exposed to prolonged medications (greater than 5 days) for cardiac procedures that may cause withdrawal upon cessation such as opioids, benzodiazepines, or other sedative medications. Participants will receive the auricular acupressure in addition to the standard of care such as clustered nursing care, touch, position change, environmental controls, holding, and swaddling.
Eligibility Criteria
Inclusion Criteria
- Infants, 34 weeks or greater gestation
- Exposure to opioids and/or benzodiazepine medications for 5 days or more
- Beginning a stable wean
- Maternal age of 18 or older
Exclusion Criteria
- Hemodynamic instability
- Transfer to another facility prior to completion of the weaning regimen
- Death
Data sourced from ClinicalTrials.gov (NCT05025384). 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.