Iatrogenic Withdrawal Syndrome
Conditions
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.
Interventions
OTHERAcupressure
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.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Participants are electronically randomized in the REDCap database.
Intervention model description
Infants will be randomized in a 1:1 ratio to two groups - intervention vs. no intervention.
Eligibility
Sex/Gender
ALL
Age
34 Weeks to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Acupressure stickers will be applied to one ear in accordance with the NADA protocol acupuncture technique.
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. | 15 |
| No Intervention No intervention | 14 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 6 |
Baseline characteristics
| Characteristic | No Intervention | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 29 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 26 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 25 Participants | 11 Participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 8 Participants | 16 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Baseline to 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupressure Intervention Group | Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) | 3.0 Score on a scale |
| Control Group | Easing of Withdrawal Symptoms as Measured by the Withdrawal Assessment Tool (WAT-1) | 3.0 Score on a scale |
Primary
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.
Time frame: Baseline to 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupressure Intervention Group | Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS) | -0.3 score in a scale |
| Control Group | Level of Sedation as Measured by the Richmond Agitation-Sedation Scale (RASS) | 0 score in a scale |
Primary
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.
Time frame: Baseline to 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Acupressure Intervention Group | Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU) | 2.0 score on a scale |
| Control Group | Presence of Delirium as Measured by the Pediatric Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU) | 2.0 score on a scale |