← Back to Search

Opioid Analgesic

Opioids for Obstructive Sleep Apnea in Children

Q: What is the upper limit for participants in this medical trial?

Absolutely. The information available on clinicaltrials.gov verifies that this study is currently enrolling patients, with a registration date of December 1st 2021 and an update to the listing occurring on December 10th 2021. This trial requires 130 participants from one location.

Q: What interventions are usually implemented to help individuals with sleep apnea and oxygen saturation below 85%?

Low oxygen saturation levels below 85% in patients with <a href="https://www.withpower.com/clinical-trials/sleep-apnea">sleep apnea</a> are often targeted using anesthesia induction therapy. This approach is also frequently employed to treat high risk surgeries, preanesthetic medications and anesthetic premedication regimens.

Q: Is the enrollment period for this clinical trial still open?

The information posted on clinicaltrials.gov indicates that this experiment is presently recruiting participants, and has been since December 1st 2021 with the last update being made on December 10th of the same year.

Q: Can individuals younger than 65 be included in this biomedical investigation?

This medical trial is recruiting participants aged between 2 and 8 years old.

Q: What eligibility criteria must be met in order to participate in this research?

The current cohort is open to 130 people aged 2-8 with opioid exposure. These participants must also fulfill the criteria of undergoing tonsillectomy or adenotonsillectomy, be between 2 and 8 years of age, and not have received any medication prior to intubation (e.g. no propofol).

Q: What prior research has been done regarding patients with sleep apnea whose oxygen saturation levels are below eighty-five percent?

Presently, 42 medical trials are studying the efficacy of oxygen saturation in patients with <a href="https://www.withpower.com/clinical-trials/sleep-apnea">sleep apnea</a>. Of those studies 10 are currently at phase 3. While most experiments have taken place in Shenzhen Guangdong province, there exists 77 other study sites worldwide investigating this intervention.

Phase < 1

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intubation without medication (e.g. no propofol prior to intubation)

Inhalation induction of anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Awards & highlights

Study Summary

This trial found that children with OSA have different responses to opioids depending on the degree of their intermittent hypoxemia.

Who is the study for?

This trial is for children aged 2 to 8 with obstructive sleep apnea who are undergoing tonsillectomy or adenotonsillectomy. They must have had a preoperative sleep study confirming the condition and require airway management during surgery. Children with syndromes, central sleep apnea, difficult airways, fentanyl allergy, cardiovascular issues, or pulmonary hypertension cannot participate.Check my eligibility

What is being tested?

The trial is studying how Fentanyl Citrate affects breathing control in children with obstructive sleep apnea during surgery. It aims to understand if intermittent low oxygen levels change the way these kids respond to opioids like Fentanyl.See study design

What are the potential side effects?

Fentanyl may cause slowed breathing, changes in blood pressure, nausea, itching or rash at the injection site. In some cases it can lead to excessive sedation or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was intubated without receiving any sedatives like propofol.

Select...

I will be put to sleep for surgery using inhaled anesthesia.

Select...

I require an LMA or ETT for airway management.

Select...

I am scheduled for a tonsil or tonsil and adenoid removal surgery.

Select...

I have been diagnosed with obstructive sleep apnea through a sleep study.

Select...

I am between 2 and 8 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Respiratory depression following opioids

Trial Design

2Treatment groups

Active Control

Group I: Patients with sleep apnea having oxygen Saturation >85%Active Control1 Intervention

Children with OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes

Group II: Patients with sleep apnea having oxygen Saturation <85%Active Control1 Intervention

Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,122 Total Patients Enrolled

University of HoustonOTHER

147 Previous Clinical Trials

47,352 Total Patients Enrolled

Children's Hospital of PhiladelphiaOTHER

708 Previous Clinical Trials

8,581,145 Total Patients Enrolled

Media Library

Fentanyl Citrate (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT05051189 — Phase < 1

Obstructive Sleep Apnea Research Study Groups: Patients with sleep apnea having oxygen Saturation >85%, Patients with sleep apnea having oxygen Saturation <85%

Obstructive Sleep Apnea Clinical Trial 2023: Fentanyl Citrate Highlights & Side Effects. Trial Name: NCT05051189 — Phase < 1

Fentanyl Citrate (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05051189 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for participants in this medical trial?

"Absolutely. The information available on clinicaltrials.gov verifies that this study is currently enrolling patients, with a registration date of December 1st 2021 and an update to the listing occurring on December 10th 2021. This trial requires 130 participants from one location."

Answered by AI

What interventions are usually implemented to help individuals with sleep apnea and oxygen saturation below 85%?

"Low oxygen saturation levels below 85% in patients with sleep apnea are often targeted using anesthesia induction therapy. This approach is also frequently employed to treat high risk surgeries, preanesthetic medications and anesthetic premedication regimens."

Answered by AI

Is the enrollment period for this clinical trial still open?

"The information posted on clinicaltrials.gov indicates that this experiment is presently recruiting participants, and has been since December 1st 2021 with the last update being made on December 10th of the same year."

Answered by AI

Can individuals younger than 65 be included in this biomedical investigation?

"This medical trial is recruiting participants aged between 2 and 8 years old."

Answered by AI

What eligibility criteria must be met in order to participate in this research?

"The current cohort is open to 130 people aged 2-8 with opioid exposure. These participants must also fulfill the criteria of undergoing tonsillectomy or adenotonsillectomy, be between 2 and 8 years of age, and not have received any medication prior to intubation (e.g. no propofol)."

Answered by AI

What prior research has been done regarding patients with sleep apnea whose oxygen saturation levels are below eighty-five percent?

"Presently, 42 medical trials are studying the efficacy of oxygen saturation in patients with sleep apnea. Of those studies 10 are currently at phase 3. While most experiments have taken place in Shenzhen Guangdong province, there exists 77 other study sites worldwide investigating this intervention."

Answered by AI

Recent research and studies

Pediatric AnesthesiaJournal

An Assessment of Opioids on Respiratory Depression in Children with and Without Obstructive Sleep Apnea

Adler, Adam C., Arvind Chandrakantan, Brian H. Nathanson, and Britta S. von Ungern‐Sternberg. 2021. “An Assessment of Opioids on Respiratory Depression in Children with and Without Obstructive Sleep Apnea”. Pediatric Anesthesia. Wiley. doi:10.1111/pan.14228.

clinicaltrials.govStudy

Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Adam Adler MD, MS, FAAP 2021. "Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05051189.

All > Apnea > Sleep Apnea