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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

Study Summary

This trial will compare the use of two different types of pain medication in children who have had sleep apnea surgery. One group of children will receive opioids (a type of narcotic pain medication), and the other group will receive nonsteroidal anti-inflammatory medications (NSAIDs). The study will compare how well each type of medication works and how safe it is.

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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Safety

Secondary outcome measures

Effectiveness

Risk Factors

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

Ibuprofen

FDA approved

Morphine

FDA approved

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,873 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

689 Previous Clinical Trials

6,945,301 Total Patients Enrolled

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

319,126 Total Patients Enrolled

Media Library

Ibuprofen (Nonsteroidal Anti-inflammatory Drug) Clinical Trial Eligibility Overview. Trial Name: NCT01680939 — Phase 3

Obstructive Sleep Apnea Syndrome Research Study Groups: Ibuprofen, Morphine

Obstructive Sleep Apnea Syndrome 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

Frequently Asked Questions

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

Which patients fit the bill for this particular experiment?

"This trial is searching for 120 individuals that have the syndrome and are between the ages of 1 and 10. Of importance, all potential participants must meet the age requirement of 1-10 years old."

Answered by AI

Does age restrict one's ability to participate in this test case?

"In order to be included in this clinical study, patients must be aged between 1 and 10 years old. Out of the 395 clinical trials taking place, 81 are for people under 18 and 314 are for people over 65."

Answered by AI

Is it safe to use Ibuprofen?

"Ibuprofen has been studied enough to where there is some data supporting its efficacy, and multiple rounds of studies have shown that it is safe. We believe that it is a 3 on a scale from 1 to 3."

Answered by AI

What are some of the conditions Ibuprofen can help alleviate?

"Ibuprofen is frequently taken to manage catarrh, but it can also help with conditions like muscle spasms, fever, and pain management."

Answered by AI

Are there other examples of Ibuprofen being used in a clinical setting?

"As of now, there are one hundred and six clinical trials involving Ibuprofen. Twenty-six of those trials are currently in Phase 3. Most of the research surrounding Ibuprofen is based in Boston, Massachusetts; however, there are two hundred and twenty-six locations conducting clinical trials for this medication."

Answered by AI