PainPhase 3MontelukastNCT02793375
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
A Phase 3 study testing Montelukast in people with Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
Objective: The purpose of the present study is to evaluate the effectiveness of preoperative Montelukast as an analgesic for adenotonsillectomy Study Design: Randomized controlled double blinded clinical trial. Read more about this study
- Who is it for?
- Ages 3 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Montelukast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2018to 19 Nov 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Exclusion Criteria: Patients with moderate to severe developmental delay will be excluded due to difficulties in scoring postoperative pain. In addition, those with allergies to Montelukast and those currently using Montelukast will be excluded. Those with moderate to severe cardiac, hepatic, pulmonary or renal disease will be excluded. All patients with a primary indication of chronic tonsillitis will be excluded. Those with active respiratory infections requiring cancellation of surgery will be excluded based on the Anesthesia services recommendations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial
Objective: The purpose of the present study is to evaluate the effectiveness of preoperative Montelukast as an analgesic for adenotonsillectomy
Study Design: Randomized controlled double blinded clinical trial.
Read more
Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery
Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized to receive either montelukast or placebo in Same Day surgery.
Analysis: Differences in demographics (age, gender, race, weight) between the intervention and control groups will be assessed using chi-square (for categorical measures) and t tests (for continuous measures). Differences in postoperative opioid usage, postoperative pain scores using the FLACC scale, and the number of postoperative contacts (Emergency department visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage will be evaluated using chi-square (categorical measures) and t tests (continuous measures).
Read the detailed description
Adenotonsillectomy (T\&A) is the one of the most common pediatric procedures performed in the United States, with over 530,000 procedures performed annually1. Pain control after T\&A is essential for improving recovery and enhancing quality of life. At CCHMC, our current protocol in patients over the age of three is to treat pain with scheduled Tylenol, ibuprofen and steroids, as well as opioids (oxycodone) as a "rescue" medication for uncontrolled pain. Despite this regimented approach, pain control is often suboptimal, and numerous doses of opioids are often required. Montelukast is a cysteinyl leukotriene receptor antagonist that may have a role in decreasing post T\&A pain2. The primary objective of the present study is to evaluate the effect of montelukast on post-T\&A pain by measuring the amount of opioid pain medication required postoperatively in patients receiving montelukast preoperatively compared to those receiving placebo. The secondary objective will evaluate post-surgical outcomes and include group comparisons of post T\&A pain scores and number of Emergency department visits and/or phone calls for perioperative pain related complaints.
Hypothesis #1 Preoperative montelukast will decrease the amount of opioid pain mediation required in the first 24 hours postoperatively compared to those in the control group.
Hypothesis #2 Preoperative montelukast will decrease pain scores in the first 24 hours after surgery in patients undergoing T\&A compared to those in the control group.
Hypothesis#3 Preoperative montelukast will decrease the number of postoperative contacts (Emergency department visits and phone calls) by parents for pain related concerns in the first 3-4 weeks after surgery.
- Conditions
- Pain
- Being tested
- Montelukast, Placebo
- Keywords
- Montelukast, Tonsillectomy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MontelukastDrug
Age appropriate dose of Montelukast given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
PlaceboDrug
Age appropriate dose of placebo given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Patients receiving placebo preoperatively (blinded) Receives: Drug: Placebo |
| Study group | Experimental | Patients receiving montelukast preoperatively (blinded) Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Physician Contacts
The number of patients that made a physician phone call and/or trip to the emergency room for pain related concerns in the first month after tonsillectomy.
Measured: within 4 weeks postop
Secondary outcomes (1)
Pain Scores
FLACC (Face, Legs, Activity, Cry, Consolability) scale scores on a scale of 0-10 (0 is no pain, 10 is worst pain)
Measured: arrival in PACU pain scores were assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start2 Aug 2018
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro D deAlarcon, MD, MPH, Principal investigator, Cincinnati Childrens Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793375
- Sponsor's protocol ID
- CIN_Montelukast_001
- Acronym
- Montelukast
- Status last verified
- Feb 2026
- First submitted
- 3 Jun 2016
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02793375
- Acronym / sponsor ID
- Montelukast / CIN_Montelukast_001
- Conditions
- Pain
- Keywords
- Montelukast, Tonsillectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: The purpose of the present study is to evaluate the effectiveness of preoperative Montelukast as an analgesic for adenotonsillectomy
Study Design: Randomized controlled double blinded clinical trial.
Setting: Cincinnati Children's Hospital Medical Center (CCHMC), Division of Pediatric Otolaryngology, Head and Neck Surgery
Methods: Children between the age of 3-8 undergoing adenotonsillectomy with planned 23 hour observation for adenotonsillar hypertrophy and sleep disordered breathing will be randomized to receive either montelukast or placebo in Same Day surgery.
Analysis: Differences in demographics (age, gender, race, weight) between the intervention and control groups will be assessed using chi-square (for categorical measures) and t tests (for continuous measures). Differences in postoperative opioid usage, postoperative pain scores using the FLACC scale, and the number of postoperative contacts (Emergency department visits or phone calls) with patients or their family regarding pain or tonsillar hemorrhage will be evaluated using chi-square (categorical measures) and t tests (continuous measures).
Detailed description
Adenotonsillectomy (T\&A) is the one of the most common pediatric procedures performed in the United States, with over 530,000 procedures performed annually1. Pain control after T\&A is essential for improving recovery and enhancing quality of life. At CCHMC, our current protocol in patients over the age of three is to treat pain with scheduled Tylenol, ibuprofen and steroids, as well as opioids (oxycodone) as a "rescue" medication for uncontrolled pain. Despite this regimented approach, pain control is often suboptimal, and numerous doses of opioids are often required. Montelukast is a cysteinyl leukotriene receptor antagonist that may have a role in decreasing post T\&A pain2. The primary objective of the present study is to evaluate the effect of montelukast on post-T\&A pain by measuring the amount of opioid pain medication required postoperatively in patients receiving montelukast preoperatively compared to those receiving placebo. The secondary objective will evaluate post-surgical outcomes and include group comparisons of post T\&A pain scores and number of Emergency department visits and/or phone calls for perioperative pain related complaints.
Hypothesis #1 Preoperative montelukast will decrease the amount of opioid pain mediation required in the first 24 hours postoperatively compared to those in the control group.
Hypothesis #2 Preoperative montelukast will decrease pain scores in the first 24 hours after surgery in patients undergoing T\&A compared to those in the control group.
Hypothesis#3 Preoperative montelukast will decrease the number of postoperative contacts (Emergency department visits and phone calls) by parents for pain related concerns in the first 3-4 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: PlaceboPatients receiving placebo preoperatively (blinded) |
| Study group | Experimental | Drug: MontelukastPatients receiving montelukast preoperatively (blinded) |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MontelukastAge appropriate dose of Montelukast given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively. | Drug | Study group |
| PlaceboAge appropriate dose of placebo given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively. | Drug | Control |
Primary outcome
Postoperative Physician Contacts
Time frame: within 4 weeks postop
The number of patients that made a physician phone call and/or trip to the emergency room for pain related concerns in the first month after tonsillectomy.
1 secondary outcome
Pain Scores
Time frame: arrival in PACU pain scores were assessed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandro D deAlarcon, MD, MPH principal investigator
Cincinnati Childrens Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast in people with Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Physician Contacts (time frame: within 4 weeks postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.