An observational study in Respiratory Depression and Obstructive Sleep Apnea, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 8 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Baylor College of Medicine · Observational
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 52 is below the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Drug: Fentanyl
Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes
Drug: Fentanyl
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
Also known as: respiratory changes, CO2, RR, TV
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
Time frame: 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
Time frame: 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
Time frame: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration
| Milestone | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea |
|---|---|---|
| Started | 21 | 31 |
| Completed | 20 | 30 |
| Not completed | 1 | 1 |
| Withdrew: Unable to establish baseline for ventilation | 1 | 1 |
Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
| percentage of change from baseline | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea |
|---|---|---|
| Respiratory Depression Following Opioids | -38.1 (-42.3 to -33.9) | -37.1 (-43.4 to -30.8) |
Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration
| percentage of change from baseline | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea |
|---|---|---|
| Respiratory Depression Following Opioids | 6.4 (-1.2 to 13.9) | 5.4 (0.0 to 10.7) |
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
| percentage of change from baseline | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea |
|---|---|---|
| Respiratory Depression Following Opioids | 4.0 (1.8 to 6.1) | 2.2 (0.2 to 4.2) |
Collected over adverse events were collected only within the study period of ten minutes. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group; Patients Without Obstructive Sleep Apnea | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Patients With Known Obstructive Sleep Apnea | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Continuous(years) | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea | Total |
|---|---|---|---|
| Mean | 4.6 ± 1.5 | 3.6 ± 1.7 | 4 ± 1.7 |
| Sex: Female, Male(Participants) | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea | Total |
|---|---|---|---|
| Female | 6 | 11 | 17 |
| Male | 14 | 19 | 33 |
| Ethnicity (NIH/OMB)(Participants) | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea | Total |
|---|---|---|---|
| Hispanic or Latino | 7 | 13 | 20 |
| Not Hispanic or Latino | 13 | 17 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 7 | 11 |
| White | 14 | 23 | 37 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Control Group; Patients Without Obstructive Sleep Apnea | Patients With Known Obstructive Sleep Apnea | Total |
|---|---|---|---|
| United States | 20 | 30 | 50 |
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Plan to share: No — No information about IP will be shared per the IRB
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine