Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit (PNCA)

Medical College of Wisconsin

Status

Completed

Conditions

Abdominal Surgery

Thoracic Surgery

Treatments

Drug: Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT01823497

FP4155

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

1 minute to 70 days old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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