Jackson Pediatric Acupressure for Opioid Tapering

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Within 24 hours of implementing a weaning protocol, acupressure will be applied to three designated points of one ear following the NADA protocol acupuncture technique while also incorporating the Near-Term Infant (NTI) conceptual framework identified elements (see figure 3). Acupressure will be administered via stickers that are adhesive to the skin like a Band-Aid (see figure 1). These stickers include a vaccaria plant seed in the center that applies continuous light pressure on the designated points. This form of acupressure was selected as it is organic and does not contain metal which may interfere with emergency medical care such as imaging. After the initial 24 hours of application, stickers will be removed, the infant's skin will be assessed for any disruption such as bruising or discoloration, and the stickers will be rotated to the infant's other ear at the same NADA protocol auricular sites. Acupressure stickers will be removed and applied to the opposite ear every 48 hours until withdrawal symptoms improve (1). Withdrawal symptoms are measured every 6 hours with the enhanced Withdrawal Assessment tool (WAT) as part of the standard of care. Upon completion of the weaning regimen, infants with a score of less than or equal to 3 or less than 2 above baseline with no more than 2 rescue medication doses in 24 hours will have the acupressure removed.

Official Title
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Auricular Acupressure as an Adjunct Treatment for Opioid Tapering in a Pediatric Cardiac Intensive Care Unit: A Pilot Feasibility Study

Conditions
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Iatrogenic Withdrawal Syndrome

Intervention / Treatment
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* Other: Acupressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 34 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. | Other: Acupressure<br>* Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique. Application will occur at designated points including Shen Men, Liver, and Lung: in the room with the mother; and potentially during breast feeding, holding, skin to skin contact or bottle feeds. Stickers will remain in place for 24 hours. At 24 hours, skin will be assessed, and stickers will then be rotated to the opposite ear every 48 - 72 hours if there are no adverse effects such as skin irritation.<br>|
| No Intervention: No Intervention<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention pilot feasibility study will assess the impact of auricular acupressure | 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). | 24 months |