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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Surgery; Thoracic Surgery
• Intervention / Treatment: Drug: Morphine

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53201
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Methadone Use	Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued.	up to 3 days after morphine is discontinued

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: Children's Hospital and Health System Foundation, Wisconsin
• Investigators: Principal Investigator: Keri R Hainsworth, PhD, Medical College of Wisconsin; Principal Investigator: Michelle L Czarnecki, MSN RN-BC CPNP, Children's Hospital and Health System Foundation, Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 2, 2013
• First Posted (Estimate): April 4, 2013

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pain; morphine; neonate; Neonatal Intensive Care Unit; Parent/Nurse Controlled Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: FP4155