Jackson Pediatric Acupressure for Opioid Tapering

January 31, 2025 updated by: Heather Jackson, Vanderbilt University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique.
Other: Acupressure

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.
No Intervention: No Intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)
Time Frame: 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.
Baseline to 72 hours
Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
Time Frame: 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.
Baseline to 72 hours
Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)
Time Frame: 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.
Baseline to 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Heather Jackson, MSN, APRN, Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Actual)

January 21, 2023

Study Completion (Actual)

January 21, 2023

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 210213

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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