Pain
Conditions
Keywords
Montelukast, Tonsillectomy
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.
Interventions
DRUGMontelukast
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.
DRUGPlacebo
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Physician Contacts | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlessandro D deAlarcon, MD, MPH
Cincinnati Childrens Hospital and Medical Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 59 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 98 Participants |
| Region of Enrollment United States | 57 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 57 |
| other Total, other adverse events | 0 / 59 | 0 / 57 |
| serious Total, serious adverse events | 0 / 59 | 0 / 57 |
Outcome results
None listed