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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 belowSelect...
I have been diagnosed with obstructive sleep apnea.
Select...
I am between 1 and 10 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have asthma.
Select...
I have had my adenoids and tonsils removed.
Select...
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
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
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.
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
340,280 Total Patients Enrolled
The Hospital for Sick ChildrenOTHER
710 Previous Clinical Trials
6,958,066 Total Patients Enrolled
University of Western Ontario, CanadaOTHER
166 Previous Clinical Trials
319,238 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have asthma.I have had my adenoids and tonsils removed.I am scheduled for a tonsillectomy, possibly with adenoid removal, at MUMC.I cannot take certain pain medications due to adverse reactions.You have any conditions related to the head, face, muscles, nerves, or heart.I have been diagnosed with obstructive sleep apnea.I am between 1 and 10 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Ibuprofen
- Group 2: Morphine
Awards:
This trial has 4 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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