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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823497
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abdominal Surgery Thoracic Surgery Drug: Morphine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parent/Nurse Controlled Analgesia for Post-Operative Pain Management in Neonates: A Preliminary Randomized Controlled Trial
Actual Study Start Date : April 2013
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Morphine Consumption [ Time Frame: 5 days post surgery ]
    The investigators will measure amount of morphine consumed post-surgery in mcg/kg/hour


Secondary Outcome Measures :
  1. Pain Control [ Time Frame: 5 days post surgery ]
    The investigators will assess pain up to 3x per hour for 3 days post-surgery. Good pain control will be defined as pain less than 4 on a 0-10 scale.


Other Outcome Measures:
  1. methadone use [ Time Frame: up to 3 days after morphine is discontinued ]
    Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued.



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Ages Eligible for Study:   up to 70 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823497


Locations
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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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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
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Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01823497    
Other Study ID Numbers: FP4155
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: October 2019
Keywords provided by Medical College of Wisconsin:
Neonatal Intensive Care Unit
neonate
pain
morphine
Parent/Nurse Controlled Analgesia
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents