Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03975192 |
| Other study ID # |
1185104 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2019 |
| Est. completion date |
October 22, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Medical College of Wisconsin |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This is a prospective pilot study to investigate the effects of Percutaneous Electrical Nerve
Field Stimulation (PENFS) on symptoms of opioid withdrawal in pediatric patients in the
intensive care unit.
Description:
This is a prospective, unblinded, randomized controlled pilot trial to evaluate the impact of
the BRIDGE device when used on patients at high risk of opioid withdrawal following opioid
exposure.
The investigator team hypothesized that treatment of pediatric intensive care unit (PICU)
patients (ages 5-17 years) with PENFS will prevent the development of opioid withdrawal
symptoms, reduce the need for long-acting opioid agonists or pharmacological rescue agents to
treat withdrawal, and decrease overall PICU length of stay (LOS).
Aim 1: Withdrawal, using the Withdrawal Assessment Tool (WAT-I) is less for those using PENFS
device than for those receiving standard of care (SOC) treatment.
H1: The WAT-I will be lower in the PENFS group than the SOC group and this will be true, even
after adjusting for age and total opioid dose/kg pre-weaning.
Aim 2: For withdrawal symptoms of nausea, vomiting or pain, those receiving PENFS compared to
SOC will require less treatment for these symptoms.
H2: The PENFS groups compared to the SOC will have primarily fewer episodes of
gastrointestinal distress and lower pain scores resulting in the use of fewer doses of rescue
medications; further this will be true after adjusting for total opioid dose/kg pre- weaning.
Aim 3: PICU LOS will be less for those receiving the PENFS device compared to those receiving
SOC treatment.
H3: Following the initiation of weaning, the PICU LOS will be less for those with PENFS than
those with SOC. This will be true after adjusting for age and total opioid dose/kg
pre-weaning.
The following inclusion and exclusion criteria will be used to determine eligibility for this
study:
Inclusion:
- Children aged 5 to 17 years
- Admission to PICU at Children's Hospital of Wisconsin (CHW)
- Exposure to at least 120 hours of continuous IV opioid administration.
Exclusion:
- Age children <5 years
- Known central nervous system injury (hypoxic ischemic injury, traumatic brain injury,
postoperative craniotomies),
- Plan to wean benzodiazepine dosing during the active study period
- Patients who are developmentally delayed
- Defined as inappropriately non-verbal for age and determined through review of the
medical record and discussion with the PICU attending and consulting team members.
- Known pregnancy
- Any pregnancy testing done during the subject's hospitalization will be reviewed.
(This will only be monitored if required as SOC, but will not be collected for the purpose of
the study alone.)
- Known seizure disorder
- Known diagnosis of psoriasis or significant dermatological disease involving ear (?)
- Patients with implantable devices (cardiac pacemaker, vagal nerve stimulator, etc.)
After consent, and prior to the initiation of opiate withdrawal initiation, subjects will be
randomized to receive the local standard methadone wean or placement of the BRIDGE device.
Randomization will be used to balance age (5-9 yrs., >9 yrs.) and gender (male, female)
assigning subjects in a 1:1 ratio to the Bridge device or control groups.
Subjects in the treatment group will have the device placed immediately following their last
scheduled opiate dose. The device will be active continuously for 120 hours from the time of
placement. As needed (PRN) dosing of pain medication will be available for breakthrough
symptoms experienced by the subject. Subjects randomized to the SOC group will begin SOC
treatment per the PICU withdrawal protocol.
The BRIDGE device will be placed per manufacturer protocol. Electrodes will be placed
percutaneously in the external ear with the help of a transilluminator to visualize the
neurovascular bundles; three electrodes will be placed on the ventral and one on the dorsal
aspect of the ear. The electrodes will be taped and secured behind the ear next to the
generator itself which is secured to the skin with adhesive.
The electrode/needle arrays are placed according to the individual's distribution of
neurovascular bundles. The exact location of the placement will vary slightly from person to
person and is determined by both knowledge of auricular neuro-anatomy and visualization of
the neurovascular bundles by transillumination (IHS, Versailles, IN, USA). The points will be
targeted by four-point electrical stimulation using the BRIDGE device after carefully
disinfecting the ear. The contents of the Neurostimulation will be delivered below sensation
threshold for 5 consecutive days (120 hours).
Removal of the device will be done by a member of the study team if the patient is still
admitted to CHW, or by the subject's parents if discharge takes place prior to the completion
of the PENFS treatment. The device will be placed in a sharps discard container after
removal. Subjects who will be discharged with the device will be provided with a sharps
disposal bag that can be used to hold the device after removal. This bag can be discarded in
any sharps container accessible to the subject or brought back to CHW and discarded the time
of their next follow up appointment. If the subject's family is not comfortable removing the
device at home the study team will make arrangements for the family to return to CHW for
device removal.
If a patient in the PENFS group is experiencing significant breakthrough withdrawal symptoms
(consistent WAT-I score of >4) for more than 48 hours, the PI and care team will meet to
discuss whether scores are due to withdrawal symptoms or are being artificially inflated due
to confounding factors. If the patient is determined to be experiencing significant symptoms
of withdrawal, the device will be removed early, and the subject will be transitioned to SOC
withdrawal treatment. At that point the patient will be considered to have withdrawn from
study.
