What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea Syndrome (OSAS) include continuous positive airway pressure (CPAP), oral appliances, and pharmacologic agents. CPAP can cause nasal congestion, dryness, and discomfort. Oral appliances may lead to jaw discomfort and dental issues. Pharmacologic treatments like opioids (e.g., morphine) can cause respiratory depression, constipation, and dependency, while nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may lead to gastrointestinal issues, increased bleeding risk, and kidney problems. It is essential to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There are no specific FDA approvals for the use of opioid analgesics like morphine or nonsteroidal anti-inflammatory drugs like ibuprofen in the treatment of Obstructive Sleep Apnea Syndrome (OSA). Current FDA-approved treatments for OSA primarily include positive airway pressure (PAP) therapy, oral appliances, and certain pharmacologic agents for managing residual sleepiness, such as modafinil and solriamfetol. Investigational approaches, including the use of carbonic anhydrase inhibitors like sulthiame, are also being explored but are not yet widely recommended.

What other types of research exist?

Promising novel alternatives to morphine and ibuprofen for Obstructive Sleep Apnea Syndrome patients include nasal expiratory positive airway pressure (PAP), oral negative pressure, upper airway muscle stimulation, and bariatric surgery. These emerging therapies aim to address the underlying causes of OSAS and offer effective treatment options beyond traditional analgesics.

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Nonsteroidal Anti-inflammatory Drug

Pain Medication Safety for Pediatric Sleep Apnea

Phase 3

Waitlist Available

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

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

Must have

Diagnosed with OSAS

Between the ages of 1-10 years

Must not have

Asthma

Has had previous adenotonsillectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial is testing morphine and ibuprofen for pain relief in young children with obstructive sleep apnea after surgery. Morphine blocks pain signals in the brain, while ibuprofen reduces swelling and pain. The goal is to find a safe and effective alternative to codeine, which has been removed due to safety concerns. Ibuprofen has been studied in various forms and doses for postoperative pain relief in children, showing it can reduce pain and the need for additional pain medication.

Who is the study for?

This trial is for children aged 1-10 years diagnosed with obstructive sleep apnea who are scheduled for tonsillectomy, possibly with adenoid removal. It's not suitable for kids with asthma, previous adenotonsillectomies, or any craniofacial, neuromuscular, or cardiac conditions.

What is being tested?

The study compares the safety and effectiveness of two painkillers—ibuprofen and morphine—in young patients after surgery for sleep apnea. The goal is to find a safe alternative to opioids like codeine.

What are the potential side effects?

Possible side effects of ibuprofen include increased risk of bleeding post-surgery. Morphine can cause drowsiness, constipation, nausea, vomiting and respiratory depression in some children.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with obstructive sleep apnea.

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I am between 1 and 10 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have asthma.

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I have had my adenoids and tonsils removed.

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I cannot take certain pain medications due to adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety

Secondary study objectives

Effectiveness

Risk Factors

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Group I: MorphineExperimental Treatment1 Intervention

Receives morphine for post-surgical pain

Group II: IbuprofenExperimental Treatment1 Intervention

Receives ibuprofen for post-surgical pain

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Morphine

FDA approved

Ibuprofen

FDA approved

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obstructive Sleep Apnea Syndrome (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, which keeps the airway open by providing a constant stream of air through a mask, and oral appliances that reposition the jaw to maintain an open airway. These treatments directly address the mechanical obstruction causing apnea. In contrast, opioid analgesics like morphine can depress respiratory function and are generally avoided in OSA patients due to the risk of exacerbating apnea episodes. NSAIDs like ibuprofen, while useful for pain management, do not directly impact the airway but are considered safer for pain relief in OSA patients compared to opioids. Understanding these mechanisms is crucial for OSA patients to avoid treatments that could worsen their condition and to focus on therapies that effectively manage their symptoms.