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Leukotriene Receptor Antagonist

Montelukast for Post-Surgery Pain (Montelukast Trial)

Phase 3

Waitlist Available

Led By Alessandro D deAlarcon, MD, MPH

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

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

Must have

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.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to first 23 hours

Awards & highlights

Montelukast Trial Summary

This trial is testing whether the drug montelukast can reduce pain for children after having their tonsils removed.

Who is the study for?

This trial is for children aged 3-8 who need surgery to remove their tonsils and adenoids due to enlargement or sleep issues, with a planned overnight stay at Cincinnati Children's Hospital. Kids with developmental delays, severe organ diseases, active respiratory infections, chronic tonsillitis, or allergies to Montelukast are not eligible.Check my eligibility

What is being tested?

The study tests if taking Montelukast before surgery can reduce pain after removing tonsils and adenoids in kids. It's a randomized trial where patients either get Montelukast or a placebo without knowing which one they receive.See study design

What are the potential side effects?

While the side effects of Montelukast aren't detailed here, common ones include stomach pain, headache, thirstiness and potential behavioral changes like agitation or aggression.

Montelukast Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 3-8 years old and scheduled for an overnight stay at CCHMC for adenotonsillectomy due to enlarged tonsils.

Montelukast Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to first 23 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to first 23 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to first 23 hours for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Opioid amount

Secondary outcome measures

Pain scores

Postoperative physician contacts

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462

16%

Cold/Upper Respiratory Infection

10%

Diarrhea

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Montelukast

Placebo

Montelukast Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study groupExperimental Treatment1 Intervention

Patients receiving montelukast preoperatively (blinded)

Group II: ControlPlacebo Group1 Intervention

Patients receiving placebo preoperatively (blinded)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Montelukast

2008

Completed Phase 4

~15460

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,479 Total Patients Enrolled

18 Trials studying Pain

4,462 Patients Enrolled for Pain

Alessandro D deAlarcon, MD, MPHPrincipal InvestigatorCincinnati Childrens Hospital and Medical Center

Media Library

Montelukast (Leukotriene Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02793375 — Phase 3

Pain Research Study Groups: Control, Study group

Pain Clinical Trial 2023: Montelukast Highlights & Side Effects. Trial Name: NCT02793375 — Phase 3

Montelukast (Leukotriene Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02793375 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

2018. "Does Montelukast Decrease Post Adenotonsillectomy Pain in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02793375.

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