Trial Outcomes & Findings for Does Montelukast Decrease Post Adenotonsillectomy Pain in Children (NCT NCT02793375)
NCT ID: NCT02793375
Last Updated: 2026-04-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
116 participants
Primary outcome timeframe
within 4 weeks postop
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Control
Patients receiving placebo preoperatively (blinded)
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.
|
Study Group
Patients receiving montelukast preoperatively (blinded)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
57
|
|
Overall Study
COMPLETED
|
59
|
57
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Montelukast Decrease Post Adenotonsillectomy Pain in Children
Baseline characteristics by cohort
| Measure |
Control
n=59 Participants
Patients receiving placebo preoperatively (blinded)
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.
|
Study Group
n=57 Participants
Patients receiving montelukast preoperatively (blinded)
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.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
59 Participants
n=13 Participants
|
57 Participants
n=13 Participants
|
116 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Continuous
|
5 years
n=13 Participants
|
5 years
n=13 Participants
|
5 years
n=26 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=13 Participants
|
28 Participants
n=13 Participants
|
58 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=13 Participants
|
29 Participants
n=13 Participants
|
58 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=13 Participants
|
7 Participants
n=13 Participants
|
14 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=13 Participants
|
48 Participants
n=13 Participants
|
98 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
2 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=13 Participants
|
57 participants
n=13 Participants
|
116 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: within 4 weeks postopThe 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.
Outcome measures
| Measure |
Experimental Group
n=57 Participants
Experimental group: Given Montelukast
|
Control Group
n=59 Participants
Control Group: Given placebo
|
|---|---|---|
|
Postoperative Physician Contacts
|
20 participants
|
24 participants
|
SECONDARY outcome
Timeframe: arrival in PACU pain scores were assessedFLACC (Face, Legs, Activity, Cry, Consolability) scale scores on a scale of 0-10 (0 is no pain, 10 is worst pain)
Outcome measures
| Measure |
Experimental Group
n=57 Participants
Experimental group: Given Montelukast
|
Control Group
n=59 Participants
Control Group: Given placebo
|
|---|---|---|
|
Pain Scores
|
1.9 FLACC scores from 0-10 (score on scale)
Standard Deviation 0.2
|
1.8 FLACC scores from 0-10 (score on scale)
Standard Deviation 0.2
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place