Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT ID: NCT02793375

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-02
• Study Completion Date: 2024-11-19

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Patients receiving placebo preoperatively (blinded)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Study group

Patients receiving montelukast preoperatively (blinded)

Group Type: EXPERIMENTAL

Montelukast

Intervention Type: 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.

Interventions

Montelukast

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro D deAlarcon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Childrens Hospital and Medical Center

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

CIN_Montelukast_001

Identifier Type: -

Identifier Source: org_study_id