Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT02793375 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CIN_Montelukast_001
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Pain

Keywords

Montelukast; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  within 4 weeks postop

Secondary Outcomes (1)

• Pain Scores

  arrival in PACU pain scores were assessed

Study Arms (2)

Control

PLACEBO COMPARATOR

Patients receiving placebo preoperatively (blinded)

Drug: Placebo

Study group

EXPERIMENTAL

Patients receiving montelukast preoperatively (blinded)

Drug: Montelukast

Interventions

Montelukast DRUG

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.

Study group

Placebo DRUG

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.

Control

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Pain

Interventions

montelukast

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Alessandro deAlarcon
• Organization: cincinnatichildrens

alessandro.dealarcon@cchmc.edu

513-636-4355

Study Officials

• Alessandro D deAlarcon, MD, MPH

  Cincinnati Childrens Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 8, 2016
• Study Start: August 2, 2018
• Primary Completion: November 19, 2024
• Study Completion: November 19, 2024
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)