Neurostimulation for Opiate Withdrawal in the PICU (NCT03975192) | Clinical Trial Compass
WithdrawnNot Applicable
Neurostimulation for Opiate Withdrawal in the PICU
Stopped: There was no enrollment.
United States0Started 2019-09-01
Plain-language 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.
Who can participate
Age range5 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.)