Status:
COMPLETED
Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Lead Sponsor:
Medical College of Wisconsin
Collaborating Sponsors:
Children's Hospital and Health System Foundation, Wisconsin
Conditions:
Abdominal Surgery
Thoracic Surgery
Eligibility:
All Genders
1-70 years
Phase:
NA
Brief Summary
The aim of this study is to examine the safety and effectiveness of 2 morphine delivery systems for post-surgical neonates. The investigators hypothesize that this study will be feasible to conduct, a...
Eligibility Criteria
Inclusion
- Surgery Location:
- Abdominal or Thoracic
- First surgery only
- Age:
- Born ≥ 34-44 weeks post-menstrual age
- Weight: Weight at birth or current weight ≥2 kg Intubated or extubated
- Prior opioid exposure:
- \< 2 days of continuous exposure
- if history of \> 2 day continuous exposure, must be off continuous drip for a week
- Intermittent exposure ≤ 2 days prior to surgery Neonates exposed to chronic opioids in utero \*In utero exposure to Selective Seretonin Reuptake Inhibitors and illicit drugs will be screened for and annotated.
- At least 1 parent is English-speaking
Exclusion
- Surgery Type:
- Cardiac, Patent Ductus Arteriosus Ligation; Omphalocele (if intubated pre-operatively)
- Diagnoses:
- • Necrotizing Enterocolitis; Diaphragmatic hernia (unless thoracoscopically repaired); Chemically or physiologically paralyzed Receiving vasopressors Receiving acetaminophen or a benzodiazepine (lorazepam or midazolam) ≤ 24 h before surgery Patients with any of the following: Epidural; Oscillating ventilator
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01823497
Start Date
April 1 2013
End Date
March 1 2019
Last Update
September 2 2020
Active Locations (1)
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1
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201