Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

Not Applicable

Completed

Conditions: Abdominal Surgery
Thoracic Surgery

Interventions: Drug: Morphine

Registration Number: NCT01823497

Lead Sponsor: Medical College of Wisconsin

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, 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent/Nurse Controlled Analgesia	Morphine	Parent/Nurse Controlled Analgesia will be the method of morphine delivery.
Continuous Opioid Infusion	Morphine	Continuous Opioid Infusion will be the method used to deliver morphine to group 2

Primary Outcome Measures

Name	Time	Method
Morphine Consumption	5 days post surgery	The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour

Secondary Outcome Measures

Name	Time	Method
Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale	4 days post surgery	The investigators will report the average pain score per POD, for 4 days (PODs 0,1,2,3). Higher scores mean worse outcome. Good pain control will be defined as pain less than 4 on a 0-10 scale. Pain is scored by observers on a minimum of 0 (no pain) to a maximum of 10 (worst pain) on this scale. The median and inter-quartile range of the average pain score per post-operative day is reported. The timeframe includes the post-operative day (POD 0), and 3 days post-surgery (POD 1-3), for a total of 4 post-operative days.