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| ID | Type | Description | Link |
|---|---|---|---|
| 11172_291 | Other Identifier | Korea Food and Drug Administrator |
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| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
| Severance Hospital | OTHER |
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The purpose of this study is to evaluate safety and efficacy of continuous infusion of remifentanil in preterm infant with mechanical ventilator for control of procedural pain using two different dosage of remifentanil.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose remifentanil | Experimental | continuous infusion of remifentanil 0.1mcg/kg/min |
|
| high dose remifentanil | Active Comparator | continuous infusion of remifentanil 0.25mcg/kg/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low dose remifentanil | Drug | non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Premature Infant Pain Profile | P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile)
| first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Reaction | bradycardia, hypotension, apnea, desaturation | during and after 10min of remifentanil continous infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Children's Hospital | Seoul | South Korea |
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This noninferiority randomized, double-blind, controlled trial was conducted at the NICU of Seoul National University Children's Hospital and Ajou University Hospital between November 2011 and April 2012
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose Remifentanil | continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
| FG001 | Low Dose Remifentanil | continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose Remifentanil | continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
| BG001 | Low Dose Remifentanil |
| 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 | Premature Infant Pain Profile | P0-P2 units on a scale ; changes in PIPP from baseline (P0) to procedure (needle puncture, P2) PIPP (preterm infant pain profile)
| Posted | Mean | Standard Deviation | units on a scale | first puncture of skin(P0), 10min after remifentanil infusion (P1), 15min after remifentanil infusion (needle puncture, P2), 10min after remifentanil stop |
|
during remifentanil infusion
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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 | High Dose Remifentanil | continuous infusion of remifentanil 0.25mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | no self respiration for 20 sec |
relatively small numbers of subjects
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pf. Han-suk Kim | Seoul National University Hospital | +82-2-2072-0647 | kimhans@snu.ac.kr |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestatonal age | Median | Full Range | days |
|
continuous infusion of remifentanil 0.1mcg/kg/min
low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
|
|
| Secondary | Adverse Reaction | bradycardia, hypotension, apnea, desaturation | Posted | Number | participants | during and after 10min of remifentanil continous infusion |
|
|
|
| 0 |
| 7 |
| 3 |
| 7 |
| EG001 | Low Dose Remifentanil | continuous infusion of remifentanil 0.1mcg/kg/min low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control | 0 | 5 | 0 | 5 |
|
| bradycardia | Cardiac disorders | Systematic Assessment | heart rate below 100/min |
|
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| D000091642 | Urogenital Diseases |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Hypotension |
|