An observational study in Obstructive Sleep Apnea, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.
Sponsored by Children's Hospital of Fudan University · Observational
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.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.
This study's enrollment of 80 is below the median of 109 across 654 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy
Inclusion Criteria:meet all of the following
Exclusion Criteria:meet anyone of the following
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.
Also known as: Fentanyl test
Rescue Morphine Requirement
Time frame: average 1 hour from extubation
Post-operative Nausea and Vomiting
Time frame: average 1 hour from extubation
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
Time frame: average 1 hour from extubation
| Milestone | The Result of Fentanyl Test |
|---|---|
| Started | 80 |
| Completed | 77 |
| Not completed | 3 |
| mg | The Result of Fentanyl Test |
|---|---|
| Rescue Morphine Requirement | 30 (20 to 40) |
| Participants | Nausea and Vomiting |
|---|---|
| Post-operative Nausea and Vomiting | 13 |
| Participants | Number of Participants With Pulse Oxygen Saturation Less Than |
|---|---|
| Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent | 7 |
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.
| Participants | The Result of Fentanyl Test |
|---|---|
| Number of Participants Who Were Light Consumers of Morphine as Identified by the Fentanyl Test | 47 |
Collected over 1 hour. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The Result of Fentanyl Test | 0/77 (0%) | 0/77 (0%) | 13/77 (16.9%) |
| Event | The Result of Fentanyl Test |
|---|---|
| vomitingGeneral disorders | 13/77 |
| Age, Categorical(Participants) | The Result of Fentanyl Test |
|---|---|
| <=18 years | 80 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | The Result of Fentanyl Test |
|---|---|
| Median | 5.2 (3.9 to 6.5) |
| Sex: Female, Male(Participants) | The Result of Fentanyl Test |
|---|---|
| Female | 65 |
| Male | 15 |
| Region of Enrollment(Participants) | The Result of Fentanyl Test |
|---|---|
| China | 80 |
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Fudan University