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Opioids for Obstructive Sleep Apnea in Children
Study Summary
This trial found that children with OSA have different responses to opioids depending on the degree of their intermittent hypoxemia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have high blood pressure in the lungs.I was intubated without receiving any sedatives like propofol.I will be put to sleep for surgery using inhaled anesthesia.I require an LMA or ETT for airway management.I am scheduled for a tonsil or tonsil and adenoid removal surgery.I have been diagnosed with obstructive sleep apnea through a sleep study.I am between 2 and 8 years old.I need to be fully asleep with IV anesthesia for my procedure.My parents have refused participation.People with specific syndromes.You have a known or suspected problem with breathing during medical procedures.You have more than 5 central sleep apnea events per hour.You are allergic to fentanyl.I do not have obstructive sleep apnea.I will be given anesthesia through an IV.I am taking medication for heart conditions.
- Group 1: Patients with sleep apnea having oxygen Saturation >85%
- Group 2: Patients with sleep apnea having oxygen Saturation <85%
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
Can individuals younger than 65 be included in this biomedical investigation?
"This medical trial is recruiting participants aged between 2 and 8 years old."
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)."
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."
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