Neurostimulation for Opiate Withdrawal in the PICU (NOW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03975192|
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opiate Withdrawal Syndrome||Device: Percutaneous Electrical Nerve Field Stimulation||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Neurostimulation on Opiate Withdrawal Symptoms in Pediatric ICU Patients|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||July 1, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Intervention Group
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
Placement of the PENFS device immediately following the last scheduled opiate dose in the PICU with active stimulation for 120 hours.
Other Name: BRIDGE Device
No Intervention: Standard of Care Group
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.
- Withdrawal Assessment Tool (WAT-1) Score [ Time Frame: Study Day 0 through Study Day 5 ]Measurement of opiate withdrawal symptoms experienced by study subjects
- Pain Medication Use [ Time Frame: Study Day 0 through Study Day 5 ]Total dose of pain medications used on each study day
- Pain Scores [ Time Frame: Study Day 0 through Study Day 5 ]Age appropriate pain score values for each study day
- Length of Stay [ Time Frame: PICU Admission ]Time PICU Admission to medical PICU discharge
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975192
|Contact: Karen Marcdante, MDfirstname.lastname@example.org|
|Contact: Kate Woods, MSemail@example.com|