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| Name | Class |
|---|---|
| University of Houston | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Wake Forest University | OTHER |
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Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
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 children 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. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg | Active Comparator | Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes. |
|
| Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl | Active Comparator | Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes |
|
| Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg | Active Comparator | Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes. |
|
| Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl | Active Comparator | Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl Citrate | Drug | Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration | respiratory rate measured at each minute for 10 consecutive minutes following opioid administration |
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration | tidal volume measured at each minute for 10 consecutive minutes following opioid administration |
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration | end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas childrens Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34053151 | Result | Adler AC, Chandrakantan A, Nathanson BH, von Ungern-Sternberg BS. An assessment of opioids on respiratory depression in children with and without obstructive sleep apnea. Paediatr Anaesth. 2021 Sep;31(9):977-984. doi: 10.1111/pan.14228. Epub 2021 Jun 16. | |
| 40914728 | Derived | Adler AC, Lin EE, Messner AH, Rosenberg TL, Pecorella S, Keleghan A, Faircloth S, Templeton TW, Harris L, Khan SA, Pednekar GS, Nguyen DT, Chandrakantan A, von Ungern-Sternberg BS. Association of preoperative nocturnal hypoxaemia nadir and fentanyl ventilatory sensitivity in children with obstructive sleep apnoea undergoing general anaesthesia: a multicentre clinical cohort study. Br J Anaesth. 2025 Nov;135(5):1518-1527. doi: 10.1016/j.bja.2025.07.059. Epub 2025 Sep 5. |
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De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI
De-identified raw data will be available upon study completion following written request to the PI. There will be no time restriction on data
Written request
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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2 groups will be identified-
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The participant will be unaware of the arm