Parent/Nurse Controlled Analgesia in the Neonatal Intensive Care Unit

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2019-03-31

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.

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Detailed Description

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Conditions

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Abdominal Surgery Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Parent/Nurse Controlled Analgesia

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine will be used to control pain post-surgery.

Continuous Opioid Infusion

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

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Morphine will be used to control pain post-surgery.

Interventions

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Morphine

Morphine will be used to control pain post-surgery.

Intervention Type DRUG

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

Minimum Eligible Age

1 Minute

Maximum Eligible Age

70 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No