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The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy;and to evaluate the ability of predicting requested dosage of morphine postoperatively.
All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Morphine Requirement | average 1 hour from extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Nausea and Vomiting | average 1 hour from extubation | |
| Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent | average 1 hour from extubation |
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Inclusion Criteria:meet all of the following
Exclusion Criteria:meet anyone of the following
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children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy
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| Name | Affiliation | Role |
|---|---|---|
| Xuan Wang | Children's Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chilren's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29164334 | Derived | Li YH, Wang X, Zhou ZJ, Zhuang PJ. Association between fentanyl test results and rescue morphine requirements in children after adenotonsillectomy. J Anesth. 2018 Feb;32(1):77-81. doi: 10.1007/s00540-017-2433-0. Epub 2017 Nov 21. |
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Children at age of 3 - 7 years with OSAS,The exclusion criteria were craniofacial deformities, mental retardation, BMI > 22 kg/m², a history of bronchial asthma, and a recent history of opioid use.
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| ID | Title | Description |
|---|---|---|
| FG000 | The Result of Fentanyl Test | The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | The Result of Fentanyl Test | The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative. |
| 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 | Rescue Morphine Requirement | Posted | Median | Inter-Quartile Range | mg | average 1 hour from extubation |
|
|
1 hour
Post-operative Nausea/vomiting (PONV) and other adverse events, such as airway obstruction, laryngospasm.
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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 | The Result of Fentanyl Test | The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Wang Xuan | the Children's Hospital of Fudan University | 18017591058 | 18017591058@163.com |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Participants |
| No |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Secondary | Post-operative Nausea and Vomiting | Posted | Count of Participants | Participants | average 1 hour from extubation |
|
|
|
| Secondary | Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent | Posted | Count of Participants | Participants | average 1 hour from extubation |
|
|
|
| Post-Hoc | Number of Participants Who Were Light Consumers of Morphine as Identified by the Fentanyl Test | The number of participants who were light consumers of morphine as identified by the Fentanyl Test,we want to know the accurate of the test.The light consumers are the children of who used total morphine <50 μg/kg. | Posted | Count of Participants | Participants | average 1 hour from extubation |
|
|
|
| 0 |
| 77 |
| 0 |
| 77 |
| 13 |
| 77 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |