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| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent/Nurse Controlled Analgesia | Active Comparator | Parent/Nurse Controlled Analgesia will be the method of morphine delivery. |
|
| Continuous Opioid Infusion | Active Comparator | Continuous Opioid Infusion will be the method used to deliver morphine to group 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine | Drug | Morphine will be used to control pain post-surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Consumption | The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour | 5 days post surgery |
| 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. |
| 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 |
Inclusion Criteria:
Surgery Location:
Age:
Prior opioid exposure:
At least 1 parent is English-speaking
Exclusion Criteria:
Surgery Type:
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
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parent/Nurse Controlled Analgesia | Parent/Nurse Controlled Analgesia will be the method of morphine delivery. Morphine: Morphine will be used to control pain post-surgery. |
| FG001 | Continuous Opioid Infusion | Continuous Opioid Infusion will be the method used to deliver morphine to group 2 Morphine: Morphine will be used to control pain post-surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parent/Nurse Controlled Analgesia | Parent/Nurse Controlled Analgesia will be the method of morphine delivery. Morphine: Morphine will be used to control pain post-surgery. |
| BG001 | Continuous Opioid Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morphine Consumption | The investigators will measure amount of morphine consumed post-surgery in mg/kg/hour | Posted | Median | Inter-Quartile Range | mg/kg/hr | 5 days post surgery |
|
Adverse events were collected up to 3 post-operative days
The intervention involved in this study would not be associated with all-cause mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parent/Nurse Controlled Analgesia | Parent/Nurse Controlled Analgesia will be the method of morphine delivery. Morphine: Morphine will be used to control pain post-surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Naloxone, reintubation, or methadone | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keri R. Hainsworth | Medical College of Wisconsin | 414-266-6306 | khainswo@mcw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2013 | Aug 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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| 4 days post surgery |
Continuous Opioid Infusion will be the method used to deliver morphine to group 2
Morphine: Morphine will be used to control pain post-surgery.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 4 days post surgery |
|
|
|
| Other Pre-specified | Methadone Use | Methadone will serve as a surrogate for tolerance and will be monitored up to 3 days after the morphine has been discontinued. | Not Posted | up to 3 days after morphine is discontinued | Participants |
| 0 |
| 16 |
| 0 |
| 16 |
| 7 |
| 16 |
| EG001 | Continuous Opioid Infusion | Continuous Opioid Infusion will be the method used to deliver morphine to group 2 Morphine: Morphine will be used to control pain post-surgery. | 0 | 9 | 0 | 9 | 5 | 9 |
| Sedation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Post-operative Day 2 |
|
| Post-operative Day 3 |
|