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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 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

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

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT01680939 — Phase 3
Childhood sleep apnea Research Study Groups: Ibuprofen, Morphine
Childhood sleep apnea Clinical Trial 2023: Ibuprofen Highlights & Side Effects. Trial Name: NCT01680939 — Phase 3
Ibuprofen (Nonsteroidal Anti-inflammatory Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01680939 — Phase 3
~9 spots leftby Nov 2025