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=5 Participants	3.6 years STANDARD_DEVIATION 1.7 • n=7 Participants	4 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	30 Participants n=7 Participants	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration

Identification 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 administration

Identification 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 administration

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

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

Dr. Adam Adler

Baylor College of Medicine7

Phone: 832-824-5801

Email: Adam.adler@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place