Jackson Pediatric Acupressure for Opioid Tapering

Not Applicable

Completed

Conditions: Iatrogenic Withdrawal Syndrome

Interventions: Other: Acupressure

Registration Number: NCT05025384

Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Acupressure	Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique.

Primary Outcome Measures

Name	Time	Method
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)	Baseline to 72 hours	The Withdrawal Assessment Tool- Version 1 (WAT-1) monitors opioid and benzodiazepine withdrawal symptoms in pediatric patients. A total of 19 withdrawal symptoms are rated where 0 indicates no symptoms and 10 is worst possible score in indicating intensity of withdrawal.
Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)	Baseline to 72 hours	Prevalence of Delirium will be reported using the preschool confusion assessment method for the ICU (psCAM-ICU). The psCAM-ICU is designed to assess for presence of delirium in critically ill children with or without mechanical ventilation. The psCAM-ICU was designed with cognitive testing that is developmentally appropriate for infants-5 years. Presence of Delirium is assessed using: 1) Acute change or fluctuating course of mental status, 2) Inattention, 3) Altered level of consciousness, 4) disorganized thinking. Presence of number 1) AND number 2) AND either number 3) OR number 4) indicates delirium is present. The following is how the data was coded: '1' for present and '2' for absent.
Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)	Baseline to 72 hours	RASS score is a 10-point scale with scores ranging from +4 (very combative, violent) to -5 (unarousable). The primary outcome was median change in RASS score between baseline (immediately before randomized intervention or standard of care) and 72 hours later.