Jackson Pediatric Acupressure for Opioid Tapering

NCT05025384 | Completed Results

• 1 other identifier: 210213
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Iatrogenic Withdrawal Syndrome

Outcome Measures

Primary Outcomes (3)

• Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)

  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)

  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)

  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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: Acupressure

No Intervention

NO INTERVENTION

No intervention

Interventions

Acupressure OTHER

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.

Intervention

Eligibility Criteria

• Age: 34 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hemodynamic instability
• Transfer to another facility prior to completion of the weaning regimen
• Death

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

Related Publications (29)

• Schwartz L, Xiao R, Brown E, Sommers E. Auricular acupressure augmentation of standard medical management of the neonatal narcotic abstinence syndrome. Medical Acupuncture. 2011;23(3):175-86.

  BACKGROUND

• Amirnovin R, Sanchez-Pinto LN, Okuhara C, Lieu P, Koh JY, Rodgers JW, Nelson LP. Implementation of a Risk-Stratified Opioid and Benzodiazepine Weaning Protocol in a Pediatric Cardiac ICU. Pediatr Crit Care Med. 2018 Nov;19(11):1024-1032. doi: 10.1097/PCC.0000000000001719.

  PMID: 30234674 BACKGROUND

• McPherson C, Inder T. Perinatal and neonatal use of sedation and analgesia. Semin Fetal Neonatal Med. 2017 Oct;22(5):314-320. doi: 10.1016/j.siny.2017.07.007. Epub 2017 Jul 19.

  PMID: 28734732 BACKGROUND

• Weber F, Van Beek S, Scoones G. Potential neurotoxicity of anesthetic drugs in young children: who cares? A survey among European anesthetists. Minerva Anestesiol. 2016 Mar;82(3):294-300. Epub 2015 Sep 3.

  PMID: 26337372 BACKGROUND

• Chen X, Wan Y, Wen K, Liang T, Lin T, Li P. [Perioperative anesthetic exposure and the neurodevelopmental status of 1 year old baby underwent neonatal cardiac surgery]. Zhong Nan Da Xue Xue Bao Yi Xue Ban. 2015 Nov;40(11):1234-8. doi: 10.11817/j.issn.1672-7347.2015.11.012. Chinese.

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• Mebius MJ, Kooi EMW, Bilardo CM, Bos AF. Brain Injury and Neurodevelopmental Outcome in Congenital Heart Disease: A Systematic Review. Pediatrics. 2017 Jul;140(1):e20164055. doi: 10.1542/peds.2016-4055. Epub 2017 Jun 13.

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• Barnett AM, Machovec KA, Ames WA, Homi HM, Turi JL, Koo J, Fuller M, Jooste EH. The effect of intraoperative methadone during pediatric cardiac surgery on postoperative opioid requirements. Paediatr Anaesth. 2020 Jul;30(7):773-779. doi: 10.1111/pan.13903. Epub 2020 Jun 25.

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• Maguire D. Care of the infant with neonatal abstinence syndrome: strength of the evidence. J Perinat Neonatal Nurs. 2014 Jul-Sep;28(3):204-11; quiz E3-4. doi: 10.1097/JPN.0000000000000042.

  PMID: 25062522 BACKGROUND

• Stuyt EB, Voyles CA, Bursac S. NADA Protocol for Behavioral Health. Putting Tools in the Hands of Behavioral Health Providers: The Case for Auricular Detoxification Specialists. Medicines (Basel). 2018 Feb 7;5(1):20. doi: 10.3390/medicines5010020.

  PMID: 29414848 BACKGROUND

• Association NAD. Acupuncture Detoxification Specialist Training and Resource Manual. Fourth ed: NADA Literature Clearinghouse; 2015. 203 p.

  BACKGROUND

• Bergdahl L, Berman AH, Haglund K. Patients' experience of auricular acupuncture during protracted withdrawal. J Psychiatr Ment Health Nurs. 2014 Mar;21(2):163-9. doi: 10.1111/jpm.12028. Epub 2012 Dec 12.

  PMID: 23230968 BACKGROUND

• Landgren K, Kvorning N, Hallstrom I. Acupuncture reduces crying in infants with infantile colic: a randomised, controlled, blind clinical study. Acupunct Med. 2010 Dec;28(4):174-9. doi: 10.1136/aim.2010.002394. Epub 2010 Oct 18.

  PMID: 20959312 BACKGROUND

• Gentry KR, McGinn KL, Kundu A, Lynn AM. Acupuncture therapy for infants: a preliminary report on reasons for consultation, feasibility, and tolerability. Paediatr Anaesth. 2012 Jul;22(7):690-5. doi: 10.1111/j.1460-9592.2011.03743.x. Epub 2011 Dec 6.

  PMID: 22141917 BACKGROUND

• Nager AL, Kobylecka M, Pham PK, Johnson L, Gold JI. Effects of acupuncture on pain and inflammation in pediatric emergency department patients with acute appendicitis: a pilot study. J Altern Complement Med. 2015 May;21(5):269-72. doi: 10.1089/acm.2015.0024. Epub 2015 Apr 15.

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• Tsai SL, Reynoso E, Shin DW, Tsung JW. Acupuncture as a Nonpharmacologic Treatment for Pain in a Pediatric Emergency Department. Pediatr Emerg Care. 2021 Jul 1;37(7):e360-e366. doi: 10.1097/PEC.0000000000001619.

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• Abbasoglu A, Cabioglu MT, Tugcu AU, Ince DA, Tekindal MA, Ecevit A, Tarcan A. Acupressure at BL60 and K3 Points Before Heel Lancing in Preterm Infants. Explore (NY). 2015 Sep-Oct;11(5):363-6. doi: 10.1016/j.explore.2015.07.005. Epub 2015 Jul 3.

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• Ecevit A, Ince DA, Tarcan A, Cabioglu MT, Kurt A. Acupuncture in preterm babies during minor painful procedures. J Tradit Chin Med. 2011 Dec;31(4):308-10. doi: 10.1016/s0254-6272(12)60009-0.

  PMID: 22462236 BACKGROUND

• Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007.

  PMID: 24078899 BACKGROUND

• Raith W, Schmolzer GM, Resch B, Reiterer F, Avian A, Koestenberger M, Urlesberger B. Laser Acupuncture for Neonatal Abstinence Syndrome: A Randomized Controlled Trial. Pediatrics. 2015 Nov;136(5):876-84. doi: 10.1542/peds.2015-0676.

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• Raith W, Urlesberger B. Laser acupuncture as an adjuvant therapy for a neonate with neonatal abstinence syndrome (NAS) due to maternal substitution therapy: additional value of acupuncture. Acupunct Med. 2014 Dec;32(6):523-4. doi: 10.1136/acupmed-2014-010638. Epub 2014 Oct 10. No abstract available.

  PMID: 25303949 BACKGROUND

• Jackson HJ, Lopez C, Miller S, Engelhardt B. A Scoping Review of Acupuncture as a Potential Intervention for Neonatal Abstinence Syndrome. Med Acupunct. 2019 Apr 1;31(2):69-84. doi: 10.1089/acu.2018.1323. Epub 2019 Apr 19.

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• Jackson HJ, Lopez C, Miller S, Englehardt B. Neonatal Abstinence Syndrome: An Integrative Review of Neonatal Acupuncture to Inform a Protocol for Adjunctive Treatment. Adv Neonatal Care. 2019 Jun;19(3):165-178. doi: 10.1097/ANC.0000000000000630.

  PMID: 31140978 BACKGROUND

• Jackson HJ, Lopez C, Miller S, Englehardt B. Feasibility of auricular acupressure as an adjunct treatment for neonatal opioid withdrawal syndrome (NOWS). Subst Abus. 2021;42(3):348-357. doi: 10.1080/08897077.2020.1784360. Epub 2020 Jul 7.

  PMID: 32635829 BACKGROUND

• Whelan KT, Heckmann MK, Lincoln PA, Hamilton SM. Pediatric Withdrawal Identification and Management. J Pediatr Intensive Care. 2015 Jun;4(2):73-78. doi: 10.1055/s-0035-1556749.

  PMID: 31110855 BACKGROUND

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Krista Vermillion
• Organization: Vanderbilt University Medical Center

krista.k.vermillion@vumc.org

615-875-1921

Study Officials

• Heather Jackson, MSN, APRN

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants are electronically randomized in the REDCap database.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Advanced Practiced Leader & Nurse Practitioner

Model Details: Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 27, 2021
• Study Start: October 25, 2021
• Primary Completion: January 21, 2023
• Study Completion: January 21, 2023
• Last Updated: February 21, 2025
• Results First Posted: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)