Neurostimulation for Opiate Withdrawal in the PICU

Withdrawn before enrolling · Not applicable

Conditions studied: Opiate Withdrawal Syndrome

In brief

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.

Key facts

Study ID

NCT03975192

Run by

Medical College of Wisconsin

People needed

0

Starts

2019-09-01

Expected to finish

2020-10-22

Last updated by the study team

2020-10-26

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.)

Where it is running

• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.