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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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to first 23 hours
Awards & highlights
Pivotal 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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid amount
Secondary study objectives
Pain scores
Postoperative physician contacts

Side effects data

From 2005 Phase 4 trial • 99 Patients • NCT00189462
16%
Cold/Upper Respiratory Infection
10%
Diarrhea
6%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Montelukast
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
838 Previous Clinical Trials
6,565,450 Total Patients Enrolled
19 Trials studying Pain
4,851 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
~16 spots leftby Dec 2025
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