Trial Outcomes & Findings for Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea (NCT NCT03938259)
NCT ID: NCT03938259
Last Updated: 2024-07-26
Results Overview
Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
Mean respiratory rate % change from baseline measured 10 minutes following opioid administration
Results posted on
2024-07-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
31
|
|
Overall Study
COMPLETED
|
20
|
30
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
unable to establish baseline for ventilation
|
1
|
1
|
Baseline Characteristics
Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Control Group; Patients Without Obstructive Sleep Apnea
n=20 Participants
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
|
Patients With Known Obstructive Sleep Apnea
n=30 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
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.6 years
STANDARD_DEVIATION 1.5 • n=99 Participants
|
3.6 years
STANDARD_DEVIATION 1.7 • n=107 Participants
|
4 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Mean respiratory rate % change from baseline measured 10 minutes following opioid administrationIdentification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Outcome measures
| Measure |
Control Group; Patients Without Obstructive Sleep Apnea
n=20 Participants
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
|
Patients With Known Obstructive Sleep Apnea
n=30 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
|
|---|---|---|
|
Respiratory Depression Following Opioids
|
-38.1 percentage of change from baseline
Interval -42.3 to -33.9
|
-37.1 percentage of change from baseline
Interval -43.4 to -30.8
|
PRIMARY outcome
Timeframe: mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administrationIdentification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration
Outcome measures
| Measure |
Control Group; Patients Without Obstructive Sleep Apnea
n=20 Participants
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
|
Patients With Known Obstructive Sleep Apnea
n=30 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
|
|---|---|---|
|
Respiratory Depression Following Opioids
|
6.4 percentage of change from baseline
Interval -1.2 to 13.9
|
5.4 percentage of change from baseline
Interval 0.0 to 10.7
|
PRIMARY outcome
Timeframe: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administrationIdentification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration
Outcome measures
| Measure |
Control Group; Patients Without Obstructive Sleep Apnea
n=20 Participants
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
|
Patients With Known Obstructive Sleep Apnea
n=30 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
|
|---|---|---|
|
Respiratory Depression Following Opioids
|
4.0 percentage of change from baseline
Interval 1.8 to 6.1
|
2.2 percentage of change from baseline
Interval 0.2 to 4.2
|
Adverse Events
Control Group; Patients Without Obstructive Sleep Apnea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Known Obstructive Sleep Apnea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place