Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

Study Overview
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Brief Summary
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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.

Official Title
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Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial

Conditions
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Abdominal Surgery, Thoracic Surgery

Intervention / Treatment
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* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 70 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parent/Nurse Controlled Analgesia<br>Parent/Nurse Controlled Analgesia will be the method of morphine delivery. | Drug: Morphine<br>* Morphine will be used to control pain post-surgery.<br>|
| Active Comparator: Continuous Opioid Infusion<br>Continuous Opioid Infusion will be the method used to deliver morphine to group 2 | Drug: Morphine<br>* Morphine will be used to control pain post-surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Consumption | The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour | 5 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale | 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. | 4 days post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatal Intensive Care Unit, neonate, pain, morphine, Parent/Nurse Controlled Analgesia