Obstructive Sleep Apnea
Conditions
Keywords
adenotonsillectomy, fentanyl
Brief summary
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.
Detailed description
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.
Interventions
DRUGFentanyl
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.
Sponsors
Children's Hospital of Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
meet all of the following 1. the American society of anesthesiologists (ASA) class Ⅰ \ Ⅱ 2. the age of 3 \ 7 years old 3. children who underwent selective adenotonsillectomy.
Exclusion criteria
meet anyone of the following 1. craniofacial malformations 2. mental retardation 3. BMI \> 22 kg/m2 4. a history of bronchial asthma 5. a recent history of opioid use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rescue Morphine Requirement | average 1 hour from extubation |
Secondary
| Measure | 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 |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | The Result of Fentanyl Test |
|---|---|
| Age, Categorical <=18 years | 80 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 5.2 years |
| Region of Enrollment China | 80 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 77 |
| other Total, other adverse events | 13 / 77 |
| serious Total, serious adverse events | 0 / 77 |
Outcome results
Primary
Rescue Morphine Requirement
Time frame: average 1 hour from extubation
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| The Result of Fentanyl Test | Rescue Morphine Requirement | 30 mg |
Secondary
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
Time frame: average 1 hour from extubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Result of Fentanyl Test | Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent | 7 Participants |
Secondary
Post-operative Nausea and Vomiting
Time frame: average 1 hour from extubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Result of Fentanyl Test | Post-operative Nausea and Vomiting | 13 Participants |
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.
Time frame: average 1 hour from extubation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| The Result of Fentanyl Test | Number of Participants Who Were Light Consumers of Morphine as Identified by the Fentanyl Test | 47 Participants |