Respiratory DepressionNCT03938259

Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

An observational study of Respiratory Depression and Obstructive Sleep Apnea, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 Read more about this study

Who is it for?: Ages 2 to 8 years
Conditions the study is for: Respiratory Depression, Obstructive Sleep Apnea
What is being tested?: Fentanyl
How many people: 52 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2019to 30 Aug 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 8 years
All sexes
No healthy volunteers
Child

Study population: 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

Who may be able to join

tonsillectomy or adenotonsillectomy
Ages 2 to 8 years
Polysomnography with AHI >6 (study group)
Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)

Who cannot join

Ages >8 years
Patients requiring pre-medication
Parental refusal
Opioid allergy/intolerance
Patients requiring propofol for intubation
Patients with known or suspected difficult airway

Show all 13Show fewer

Obesity with body mass index exceeding 30- (control group only)
Known cardiovascular disorders
Known pulmonary disorders aside from asthma
Patients with chronic oxygen requirement
History of Prematurity <35 weeks of gestation
No recent URI
Personal of family history of malignant hyperthermia

Trial locations and contacts

1 site in 1 country.

United States1 site

Texas childrens Hospital
Houston, Texas, 77030

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Respiratory Depression, Obstructive Sleep Apnea
Being tested: Fentanyl
Keywords: pediatrics, opioids, obstructive sleep apnea
Medical subject headings: Respiratory Insufficiency, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FentanylDrug
Also called respiratory changes, CO2, RR, TV
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA

Study groups in NCT03938259
Study group	Role	What they receive
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 Receives: Drug: Fentanyl
Patients with known obstructive sleep apnea		Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes Receives: Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201930 Aug 2020

First posted6 May 2019
Study start1 Jul 2019
Primary completion30 Aug 2020
Study completion30 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory DepressionStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03938259
Sponsor's protocol ID: H-45486
Status last verified: Feb 2024
First submitted: 27 Apr 2019
Last updated: 26 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No information about IP will be shared per the IRB

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Respiratory Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
ClinicalTrials.gov ID: NCT03938259
Acronym / sponsor ID: H-45486
Conditions: Respiratory Depression, Obstructive Sleep Apnea
Keywords: pediatrics, opioids, obstructive sleep apnea
Study type: Observational
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Study start: 1 Jul 2019 (actual)
Primary completion: 30 Aug 2020 (actual)
Study completion: 30 Aug 2020 (actual)
First posted: 6 May 2019 (actual)
Results: Posted 26 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Control group; patients without obstructive sleep apnea	–	Drug: FentanylChildren without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Patients with known obstructive sleep apnea	–	Drug: FentanylChildren with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes

Who may qualify

Ages: 2 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: 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

Key inclusion criteria (4 listed)

tonsillectomy or adenotonsillectomy
Ages 2 to 8 years
Polysomnography with AHI >6 (study group)
Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)

Key exclusion criteria (13 listed)

Ages >8 years
Patients requiring pre-medication
Parental refusal
Opioid allergy/intolerance
Patients requiring propofol for intubation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FentanylAlso: respiratory changes, CO2, RR, TVidentification of respiratory parameter changes following administration of fentanyl in children with and without OSA	Drug	Control group; patients without obstructive sleep apnea, Patients with known obstructive sleep apnea

Primary outcome

Respiratory Depression Following Opioids
Time frame: 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
Respiratory Depression Following Opioids
Time frame: 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
Respiratory Depression Following Opioids
Time frame: 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

Results and safety

Results posted to the registry on 26 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group; Patients Without Obstructive Sleep Apnea	21	20
Patients With Known Obstructive Sleep Apnea	31	30

Primary outcome: Respiratory Depression Following Opioids

Time frame: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration. Mean (95% Confidence Interval). Unit: percentage of change from baseline

Measure	Control Group; Patients Without Obstructive Sleep Apnea n = 20	Patients With Known Obstructive Sleep Apnea n = 30
Value	-38.1 (-42.3 to -33.9)	-37.1 (-43.4 to -30.8)

Primary outcome: Respiratory Depression Following Opioids

Time frame: mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration. Mean (95% Confidence Interval). Unit: percentage of change from baseline

Measure	Control Group; Patients Without Obstructive Sleep Apnea n = 20	Patients With Known Obstructive Sleep Apnea n = 30
Value	6.4 (-1.2 to 13.9)	5.4 (0.0 to 10.7)

Primary outcome: Respiratory Depression Following Opioids

Time frame: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration. Mean (95% Confidence Interval). Unit: percentage of change from baseline

Measure	Control Group; Patients Without Obstructive Sleep Apnea n = 20	Patients With Known Obstructive Sleep Apnea n = 30
Value	4.0 (1.8 to 6.1)	2.2 (0.2 to 4.2)

Adverse events

Time frame: adverse events were collected only within the study period of ten minutes. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group; Patients Without Obstructive Sleep Apnea	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Patients With Known Obstructive Sleep Apnea	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No information about IP will be shared per the IRB

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

adam adler, MD principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Depression and Obstructive Sleep Apnea, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Depression Following Opioids (time frame: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03938259.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.