OSAEarly Phase 1NCT05051189
Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
A Early Phase 1 study testing Fentanyl Citrate in people with OSA and Opioid, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- OSA, Opioid, Adenotonsillectomy
- What is being tested?
- Fentanyl Citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 1 Nov 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients undergoing tonsillectomy or adenotonsillectomy
- Ages 2 to up to 8 years
- Preoperative sleep study demonstrating obstructive sleep apnea
- Intubation without medication (e.g. no propofol prior to intubation)
- Requirement for airway instrumentation: LMA or ETT
- Inhalation induction of anesthesia
Who cannot join
- No obstructive sleep apnea
- Central sleep apnea events >5/hour
- IV induction of anesthesia
- Syndromic patients
- Known or suspected difficult airway
- Allergy to Fentanyl
Show all 10Show fewer
- Known cardiovascular medications
- Pulmonary hypertension
- Total intravenous anesthesia required
- Parental refusal
Trial locations and contacts
1 site in 1 country.
About this study
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
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 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.
- Conditions
- OSA, Opioid, Adenotonsillectomy
- Being tested
- Fentanyl Citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fentanyl Citrate |
| 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 Receives: Drug: Fentanyl Citrate |
| 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. Receives: Drug: Fentanyl Citrate |
| 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. Receives: Drug: Fentanyl Citrate |
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 fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Measured: 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
Measured: 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
Measured: end tidal co2 measured at each minute for 10 consecutive 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.
- First posted21 Sep 2021
- Study start1 Dec 2021
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OSAStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will be identified- 1. patients with sleep study O2 nadir \>85% 2. patients with sleep study O2 nadir \<85%
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Children's Hospital of Philadelphia, Wake Forest University
- Responsible party
- Principal investigator, Adam Adler MD, MS, FAAP, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051189
- Sponsor's protocol ID
- H50267
- Status last verified
- Apr 2025
- First submitted
- 2 Sep 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI
Publications
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.
PubMed 34053151Adler 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.
PubMed 40914728
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05051189
- Acronym / sponsor ID
- H50267
- Conditions
- OSA, Opioid, Adenotonsillectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- University of Houston, Children's Hospital of Philadelphia, Wake Forest University
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- 2 groups will be identified- 1. patients with sleep study O2 nadir >85% 2. patients with sleep study O2 nadir <85%
| Arm | Type | Receives |
|---|---|---|
| Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg | Active comparator | Drug: Fentanyl CitrateChildren 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 | Drug: Fentanyl CitrateChildren 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 | Drug: Fentanyl CitrateChildren 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 | Drug: Fentanyl CitrateChildren 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients undergoing tonsillectomy or adenotonsillectomy
- Ages 2 to up to 8 years
- Preoperative sleep study demonstrating obstructive sleep apnea
- Intubation without medication (e.g. no propofol prior to intubation)
- Requirement for airway instrumentation: LMA or ETT
Key exclusion criteria (10 listed)
- No obstructive sleep apnea
- Central sleep apnea events >5/hour
- IV induction of anesthesia
- Syndromic patients
- Known or suspected difficult airway
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 |
|---|---|---|
| Fentanyl CitrateVentilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV | Drug | Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl, Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl, Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg, Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg |
Primary outcome
Respiratory depression following opioids
Time frame: respiratory rate measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
Respiratory depression following opioids
Time frame: tidal volume measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration
Respiratory depression following opioids
Time frame: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Results publication: PubMed 34053151Adler 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.
- Derived from this study: PubMed 40914728Adler 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.
- Individual participant dataSharing planned: Yes. De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fentanyl Citrate in people with OSA and Opioid, 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 6 inclusion and 10 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 6 Apr 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: respiratory rate measured at each minute for 10 consecutive 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 NCT05051189, which also lists 2 linked publications.
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 6 Apr 2025.