Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

NCT01823497 | Completed Results

• 1 other identifier: FP4155
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Surgery; Thoracic Surgery

Keywords

Neonatal Intensive Care Unit; neonate; pain; morphine; Parent/Nurse Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption

  The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour

  5 days post surgery

Secondary Outcomes (1)

• Revised-Face, Legs, Activity, Cry, Consolability (Revised-FLACC) Scale

  4 days post surgery

Other Outcomes (1)

• Methadone Use

  up to 3 days after morphine is discontinued

Study Arms (2)

Parent/Nurse Controlled Analgesia

ACTIVE COMPARATOR

Parent/Nurse Controlled Analgesia will be the method of morphine delivery.

Drug: Morphine

Continuous Opioid Infusion

ACTIVE COMPARATOR

Continuous Opioid Infusion will be the method used to deliver morphine to group 2

Drug: Morphine

Interventions

Morphine DRUG

Morphine will be used to control pain post-surgery.

Continuous Opioid Infusion; Parent/Nurse Controlled Analgesia

Eligibility Criteria

• Age: 1 Minute - 70 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Keri R. Hainsworth
• Organization: Medical College of Wisconsin

khainswo@mcw.edu

414-266-6306

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: April 4, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: September 2, 2020
• Results First Posted: September 2, 2020

Record last verified: 2020-08

Locations

US (1)