Neurostimulation for Opiate Withdrawal in the PICU

NCT03975192 | Withdrawn DMC FDA Device

• 1 other identifier: 1185104
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opiate Withdrawal Syndrome

Keywords

Opiate Withdrawal; Neurostimulation; Percutaneous Electric Nerve Field Stimulation; Pediatrics; Pediatric Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Withdrawal Assessment Tool (WAT-1) Score

  Measurement of opiate withdrawal symptoms experienced by study subjects

  Study Day 0 through Study Day 5

Secondary Outcomes (3)

• Pain Medication Use

  Study Day 0 through Study Day 5

• Pain Scores

  Study Day 0 through Study Day 5

• Length of Stay

  PICU Admission

Study Arms (2)

Intervention Group

EXPERIMENTAL

50% of subjects will be randomized to the Intervention group and will receive percutaneous electric nerve field stimulation (PENFS) through the BRIDGE Device for 120 hours to treat withdrawal symptoms in patients following opiate exposure in the PICU.

Device: Percutaneous Electrical Nerve Field Stimulation

Standard of Care Group

NO INTERVENTION

50% of subjects will be randomized to the Standard of Care group and will receive be started on the standardized PICU Methadone wean for patients following opiate exposure in the PICU.

Interventions

Percutaneous Electrical Nerve Field Stimulation DEVICE

Placement of the PENFS device immediately following the last scheduled opiate dose in the PICU with active stimulation for 120 hours.

Also known as: BRIDGE Device

Intervention Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• o 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
• o 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.)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study subject will be randomized to receive study treatment (PENFS device treatment) or the Standard of Care treatment (Methadone wean) for prevention of opiate withdrawal symptoms

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: September 1, 2019
• Primary Completion: October 22, 2020
• Study Completion: October 22, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)