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Completed

NCT Number: NCT02793375

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

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).

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain Scores

    Time frame: arrival in PACU pain scores were assessed

    FLACC (Face, Legs, Activity, Cry, Consolability) scale scores on a scale of 0-10 (0 is no pain, 10 is worst pain)

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children? A Randomized Controlled Trial

Acronym: Montelukast

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2016
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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