Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit
Completed · Not applicable
Conditions studied: Abdominal Surgery, Thoracic Surgery
In brief
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, and that neonates receiving morphine via a Parent/Nurse Controlled Analgesia pump will receive less morphine and experience fewer side effects than neonates receiving morphine via continuous opioid infusion.
Key facts
- Study ID
- NCT01823497
- Run by
- Medical College of Wisconsin
- People needed
- 36
- Starts
- 2013-04-01
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2020-09-02
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
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.