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Montelukast for Post-Surgery Pain (Montelukast Trial)
Montelukast Trial Summary
This trial is testing whether the drug montelukast can reduce pain for children after having their tonsils removed.
Montelukast Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMontelukast Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2005 Phase 4 trial • 99 Patients • NCT00189462Montelukast Trial Design
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Who is running the clinical trial?
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- I am between 3-8 years old and scheduled for an overnight stay at CCHMC for adenotonsillectomy due to enlarged tonsils.I do not have a respiratory infection that would require canceling surgery.I do not have severe heart, liver, lung, or kidney disease.I do not have chronic tonsillitis.I am not allergic to Montelukast and am not currently taking it.
- Group 1: Control
- Group 2: Study group
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 extent of Montelukast's clinical research history?
"There are currently 22 ongoing clinical trials studying the efficacy of Montelukast. Of these, 6 are in Phase 3. Most trial locations for this medication are situated in Lexington, Kentucky; however, there are a total of 221 facilities conducting research on Montelukast."
Does Montelukast have any harmful side effects?
"Montelukast's Phase 3 status indicates that, while there is some efficacy data available, the drug has undergone multiple rounds of testing to establish its safety."
Does this study involve individuals who are older than 25 years?
"Per the requirements for this study, 3-8 year olds are eligible to participate."
How is montelukast most commonly employed?
"Montelukast is frequently used to mitigate exercise-induced bronchospasm but can also be employed to manage other conditions such as perennial allergic rhinitis (par), seasonal allergic rhinitis, and asthma."
Is this a fully enrolled study or are there still opportunities for people to participate?
"That is correct, the online clinicaltrials.gov registry currently recruiting participants for this study. The listing was first published on August 2nd, 2018 with the most recent update being June 7th, 2022. So far, 1 site has enrolled 120 individuals in total."
To qualify for this clinical trial, who must meet the eligibility requirements?
"Children aged 3 to 8 who have pain and meet the following conditions are welcome in this clinical trial: Inclusion Criteria: All patients between the ages of 3-8 undergoing adenotonsillectomy for an indication of adenotonsillar hypertrophy who are scheduled for overnight 23 hour observation at CCHMC main campus."
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