Clinical trial NCT05025384: Jackson Pediatric Acupressure for Opioid Tapering
Official title: Auricular Acupressure as an Adjunct Treatment for Opioid Tapering in a Pediatric Cardiac Intensive Care Unit: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iatrogenic Withdrawal Syndrome
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 34
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1)
timeFrame: Baseline to 72 hours
measure: Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)
timeFrame: Baseline to 72 hours
measure: Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS)
timeFrame: Baseline to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Heather Jackson, MSN, APRN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Gupta P, Whiteside W, Sabati A, Tesoro TM, Gossett JM, Tobias JD, Roth SJ. Safety and efficacy of prolonged dexmedetomidine use in critically ill children with heart disease*. Pediatr Crit Care Med. 2012 Nov;13(6):660-6. doi: 10.1097/PCC.0b013e318253c7f1.
citation: Edwards L, Brown LF. Nonpharmacologic Management of Neonatal Abstinence Syndrome: An Integrative Review. Neonatal Netw. 2016;35(5):305-13. doi: 10.1891/0730-0832.35.5.305.
citation: 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.
citation: 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.
citation: Association NAD. Acupuncture Detoxification Specialist Training and Resource Manual. Fourth ed: NADA Literature Clearinghouse; 2015. 203 p.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Yang C, Hao Z, Zhang LL, Guo Q. Efficacy and safety of acupuncture in children: an overview of systematic reviews. Pediatr Res. 2015 Aug;78(2):112-9. doi: 10.1038/pr.2015.91. Epub 2015 May 7.
citation: 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.
citation: Chen KL, Lindrea KB, Quah-Smith I, Schmolzer GM, Daly M, Schindler T, Oei JL. Magnetic noninvasive acupuncture for infant comfort (MAGNIFIC) - a single-blinded randomised controlled pilot trial. Acta Paediatr. 2017 Nov;106(11):1780-1786. doi: 10.1111/apa.14002. Epub 2017 Aug 29.
citation: Chen LL, Su YC, Su CH, Lin HC, Kuo HW. Acupressure and meridian massage: combined effects on increasing body weight in premature infants. J Clin Nurs. 2008 May;17(9):1174-81. doi: 10.1111/j.1365-2702.2007.02147.x.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.