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The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea
Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in adults suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group; patients without obstructive sleep apnea | Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes |
| |
| Patients with known obstructive sleep apnea | Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration | Mean respiratory rate % change from baseline measured 10 minutes following opioid administration |
| Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration | mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration |
| Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration | mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration |
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Inclusion Criteria:
Exclusion Criteria:
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We are assessing the effect of fentanyl on children with and without OSA based on the OSA 18 questionnaire and PSG resepctively. Children must be otherwise healthy as stated above in the eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| adam adler, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas childrens Hospital | Houston | Texas | 77030 | United States |
No information about IP will be shared per the IRB
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group; Patients Without Obstructive Sleep Apnea | Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
| FG001 | Patients With Known Obstructive Sleep Apnea | Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group; Patients Without Obstructive Sleep Apnea | Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration | Posted | Mean | 95% Confidence Interval | percentage of change from baseline | Mean respiratory rate % change from baseline measured 10 minutes following opioid administration |
|
adverse events were collected only within the study period of ten minutes
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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 | Control Group; Patients Without Obstructive Sleep Apnea | Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Adler | Baylor College of Medicine7 | 832-824-5801 | Adam.adler@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2019 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Patients With Known Obstructive Sleep Apnea |
Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA |
|
|
| Primary | Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration | Posted | Mean | 95% Confidence Interval | percentage of change from baseline | mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration |
|
|
|
| Primary | Respiratory Depression Following Opioids | Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration | Posted | Mean | 95% Confidence Interval | percentage of change from baseline | mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Patients With Known Obstructive Sleep Apnea | Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes Fentanyl: identification of respiratory parameter changes following administration of fentanyl in children with and without OSA | 0 | 30 | 0 | 30 | 0 | 30 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |