Trial Outcomes & Findings for Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy (NCT NCT04066829)
NCT ID: NCT04066829
Last Updated: 2022-11-01
Results Overview
Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
198 participants
Primary outcome timeframe
Day of discharge, approximately 1 day
Results posted on
2022-11-01
Participant Flow
282 participants were eligible of whom data from 237 participants was used. 198 consented; the other 39 could not be approached for consent. The IRB approved analysis of Electronic Medical Record data for these patients for the primary outcomes only, determining that review of electronic medical record data was no more than minimal risk and was justified to maximize sample size and power in light of decreased tonsillectomy volume at the University of Michigan owing to COVID-19.
45 participants who were initially eligible to participate in the study were excluded because they declined to participate, withdrew or did not undergo a tonsillectomy, did not receive a discharge opioid prescription, had prior opioid use, or opted for an opioid sparing pathway.
Participant milestones
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
October 1, 2019 - September 30, 2020 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
October 1, 2020 - July 31, 2021 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
October 1, 2019 - September 30, 2020 The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
October 1, 2020 - July 31, 2021 The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
70
|
61
|
46
|
60
|
|
Overall Study
Participants Who Completed the Post-operative Day 14 Survey Assessing Secondary Outcomes.
|
44
|
40
|
26
|
40
|
|
Overall Study
COMPLETED
|
70
|
61
|
46
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy
Baseline characteristics by cohort
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021 The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020 The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021 The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Ages 12 years to 17 years
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Age, Customized
Ages 18 years to 25 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Female
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
147 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White/Non-Hispanic
|
54 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/Non-Hispanic
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Any Race
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian/Non-Hispanic
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other/Multi-Racial/Non-Hispanic
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown Race or Ethnicity
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
70 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
237 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of discharge, approximately 1 dayDoses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Number of Doses in the Initial Discharge Opioid Prescription
|
22.3 Doses
Standard Deviation 7.4
|
16.1 Doses
Standard Deviation 6.5
|
33.7 Doses
Standard Deviation 20.4
|
30.4 Doses
Standard Deviation 12.4
|
PRIMARY outcome
Timeframe: Day of discharge, approximately 1 dayThe new default settings called for 12 doses in the discharge prescription. This measure assesses the proportion of participants with 12 doses in the discharge prescription, regardless of which arm they were in. Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings
|
1 Participants
|
27 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 14Doses are defined as the maximum number of instances a patient could take opioids if they took them as prescribed. Number of doses are calculated from the electronic health record.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery
|
10 Participants
|
12 Participants
|
25 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Day 14Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 14Detailed in electronic health record
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=70 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=61 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=46 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=60 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Participants were surveyed on Day 14 and asked to report level of satisfaction with pain control since their surgery. Pain control satisfaction is on a scale of 1-10 with higher scores indicating higher satisfaction
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
7.4 units on a scale
Standard Deviation 2.4
|
7.4 units on a scale
Standard Deviation 2.4
|
6.5 units on a scale
Standard Deviation 2.5
|
6.7 units on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.
|
32 Participants
|
25 Participants
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Survey was comprised of 5 options: * Much worse than you expected * Worse than you expected * About what you expected * Better than you expected * Much better than you expected
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.
|
15 Participants
|
11 Participants
|
11 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Survey asked participant on what day pain had resolved. If participants indicated pain had resolved by Day 14, then they were coded as 1, and 0 otherwise.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.
|
32 Participants
|
34 Participants
|
17 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Pain control is on a scale of 0-10 with higher scores indicating more pain.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.
|
5.3 score on a scale
Standard Deviation 2.8
|
5.4 score on a scale
Standard Deviation 3.2
|
7.1 score on a scale
Standard Deviation 2.0
|
6.4 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Pain control is on a scale of 0-10 with higher scores indicating worse pain.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.
|
3.3 score on a scale
Standard Deviation 2.1
|
3.3 score on a scale
Standard Deviation 3.0
|
4.4 score on a scale
Standard Deviation 2.0
|
3.9 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Participants who answered 'No' to the following question: Did you take all of the opioid pain medications that were prescribed to you during the two weeks after surgery?
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=38 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=38 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.
|
35 Participants
|
28 Participants
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Patients were asked to report the number of instances in which they used opioids prescribed to them.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=41 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=36 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=33 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
7.2 Opioid Doses Consumed
Standard Deviation 8.0
|
9.5 Opioid Doses Consumed
Standard Deviation 9.6
|
27.3 Opioid Doses Consumed
Standard Deviation 18.7
|
23.3 Opioid Doses Consumed
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Includes any use of opioids prescribed to others
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=38 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Misused Opioids Prescribed to Others at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Includes taking one's own opioids in greater amounts, more often, or longer than directed by a doctor.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=38 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Misused Opioids Prescribed to Them at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
This is an 8-item self-report scale, all items are rated on a score of 0-3, for a total range of 0-24. Higher scores indicate more depressive symptoms
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=43 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=26 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.
|
5.1 score on a scale
Standard Deviation 5.6
|
5.6 score on a scale
Standard Deviation 4.9
|
7.4 score on a scale
Standard Deviation 4.4
|
7.6 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
This measure is 8 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater anxiety,
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=42 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.
|
11.2 score on a scale
Standard Deviation 4.6
|
12.4 score on a scale
Standard Deviation 6.1
|
15.9 score on a scale
Standard Deviation 8.1
|
13.4 score on a scale
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
This measure is 4 items each scored from 1 to 5 points, with the lowest possible raw score being 8 and the highest possible raw score being 40. Higher scores indicate greater sleep disturbance, i.e. worse sleep.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=42 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=39 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.
|
8.4 score on a scale
Standard Deviation 2.9
|
9.7 score on a scale
Standard Deviation 3.7
|
12.2 score on a scale
Standard Deviation 4.0
|
11.2 score on a scale
Standard Deviation 42
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Saw Their Primary Care Doctor (or a Colleague) in the Office Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Visited a Retail Clinic Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Visited an Urgent Care Center Due to Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: The numbers above reflect the number of participants with complete data for this outcome measure.
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=44 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=25 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=40 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients Who Visited an Emergency Department and/or Were Hospitalized Due to Poorly Controlled Pain at Least Once During the Two Weeks After Surgery as Measured by the Post-operative Survey.
|
3 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 14 DaysPopulation: The numbers above reflect the number of participants with complete data for this outcome measure.
Proportion of patients with leftover doses who disposed of them
Outcome measures
| Measure |
Pediatric Otolaryngology Service (Pre-Intervention)
n=34 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
Pediatric Otolaryngology Service (Post-Intervention)
n=25 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at C.S. Mott Hospital by a pediatric otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Pre-Intervention)
n=19 Participants
October 1, 2019 - September 30, 2020
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
General Otolaryngology Service (Control, Post-Intervention)
n=23 Participants
October 1, 2020 - July 31, 2021
The arm included all patients undergoing tonsillectomy at University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care by a general otolaryngology faculty member at the University of Michigan.
|
|---|---|---|---|---|
|
Proportion of Patients With Leftover Doses Who Disposed of Them
|
28 Participants
|
17 Participants
|
13 Participants
|
17 Participants
|
Adverse Events
Pediatric Otolaryngology Service (Pre-Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pediatric Otolaryngology Service (Post-Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Otolaryngology Service (Control, Pre-Intervention)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
General Otolaryngology Service (Control, Post-Intervention)
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