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A high incidence of respiratory morbidity after adenotonsillectomy is reported in children with obstructive sleep apnea syndrome (OSAS). So we designed a prospective, double-blind, randomized controlled study to determine the effects of individualized opioid analgesia compared with conventional opioid analgesia on respiratory morbidity after adenotonsillectomy in Children with OSAS.
All children were randomized 2 groups based on a computer-generated random number. The main interventions were occurred in post anesthetic care unit (PACU). In the operating room, all patients received a standardized anesthetic regimen by one anesthetist. 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 intravenous injection 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. The result of fentanyl test submitted to assistant, and prepared the rescue analgesic drugs according to this result. One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine. Another group: all received 25μg/kg morphine .The trachea was extubated when patients were awake, and then transported to the PACU. Patients with a Children's Hospital of Eastern Ontario Pain Scale score>6 received rescue analgesic drugs and observe respiratory morbidity in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized opioid analgesia | Other | One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. |
|
| conventional opioid analgesia | Other | Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized opioid analgesia | Drug | (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events | The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%. | Time from entering the PACU until the patient leaves,approx 1 hour. |
| Measure | Description | Time Frame |
|---|---|---|
| The Median Survival Time for CHEOPS Score > 6. | Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups. | Time from entering the PACU until the patient leaves,approx 1 hour. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 33557762 | Derived | Guo J, Zhuang P, Liu K, Wan Y, Wang X. Effects of an individualized analgesia protocol on the need for medical interventions after adenotonsillectomy in children: a randomized controlled trial. BMC Anesthesiol. 2021 Feb 8;21(1):41. doi: 10.1186/s12871-021-01263-3. |
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Patients with a history of allergy, pulmonary or cardiac diseases were excluded.
children who scheduled for adenotonsillectomy under general anesthesia
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| ID | Title | Description |
|---|---|---|
| FG000 | Individualized Opioid Analgesia | One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine. |
| FG001 | Conventional Opioid Analgesia | Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. conventional opioid analgesia: (b) all received 25μg/kg morphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Individualized Opioid Analgesia | One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine. |
| BG001 | Conventional Opioid Analgesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Percentage of Patients Requiring at Least One Medical Intervention for Respiratory Events | The medical interventions included instrumentation of the airway, bag/mask ventilation, and/or drug administration (succinylcholine, albuterol, or naloxone), which were classified as major medical interventions. The medical interventions also included repositioning of the child's airway, chin lift/jaw thrust maneuvers, and/or escalating to an oxygen mask, which were classified as minor medical interventions. Since oxygen by nasal cannula was delivered to all children recovering from anesthesia, escalating to an oxygen mask implied the patient need but higher concentration of oxygen to maintain SpO2 ≥ 95%. | Posted | Count of Participants | Participants | Time from entering the PACU until the patient leaves,approx 1 hour. |
|
Time from entering the PACU until the patient leaves,approx 1 hour.
Respiratory adverse events were defined as an intervention requiring a nurse to maintain the SPO2 ≥95%.
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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 | Individualized Opioid Analgesia | One group: positive result 10μg/kg morphine; negative result 50μg/kg morphine.Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. personalized opioid analgesia: (a）positive result 10μg/kg morphine; negative result 50μg/kg morphine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Operative Nausea And Vomitting | Surgical and medical procedures | Systematic Assessment |
The absence of PSG assessment before surgery in patients recruited in this study is a limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Wang Xuan | the Children's Hospital of Fudan University | 18017591058 | 744734170@qq.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 15, 2017 | Feb 26, 2018 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 15, 2017 | Feb 26, 2018 | ICF_004.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 15, 2017 | Nov 6, 2018 | Prot_005.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| conventional opioid analgesia | Device | (b) all received 25μg/kg morphine |
|
|
Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. conventional opioid analgesia: (b) all received 25μg/kg morphine |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | The children with cough after intravenous fentanyl, the study was excluded | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Inter-Quartile Range | kg / m^2 |
|
| OG001 | Conventional Opioid Analgesia | Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. conventional opioid analgesia: (b) all received 25μg/kg morphine |
|
|
|
| Secondary | The Median Survival Time for CHEOPS Score > 6. | Pain was assessed and recorded through the East Ontario children's hospital pain score (CHEOPS).When the CHEOPS>6,We thought it is painful. Comparing the median survival time (the time corresponding to pain percentage of 50% in two groups) for CHEOPS>6 in two groups. | Posted | Median | 95% Confidence Interval | minute | Time from entering the PACU until the patient leaves,approx 1 hour. |
|
|
|
| 16 |
| 134 |
| 0 |
| 134 |
| 16 |
| 134 |
| EG001 | Conventional Opioid Analgesia | Another group: all received 25μg/kg morphine .Scored every 10 minutes until CHEOPS<=6 and Aldrete score>9. conventional opioid analgesia: (b) all received 25μg/kg morphine | 29 | 130 | 0 | 130 | 22 | 130 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|