N/A N=237 Health Services Research

Default Dosing Settings for Opioid Prescriptions to Adolescents and Young Adults After Tonsillectomy

Tonsillectomy

Bottom Line

View on ClinicalTrials.gov: NCT04066829 ↗

Enrolled (actual)

237

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcome: Primary: Number of Doses in the Initial Discharge Opioid Prescription — 22.3; 16.1; 33.7; 30.4 Doses

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Default setting intervention (Behavioral)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Doses in the Initial Discharge Opioid Prescription	22.3; 16.1; 33.7; 30.4	—
PRIMARY 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; 27; 2; 0	—
PRIMARY Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery	10; 12; 25; 26	—
PRIMARY Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery	2; 1; 0; 1	—
PRIMARY 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; 2; 2; 3	—
SECONDARY Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey.	7.4; 7.4; 6.5; 6.7	—
SECONDARY Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey.	32; 25; 11; 18	—
SECONDARY Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey.	15; 11; 11; 18	—
SECONDARY Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey.	32; 34; 17; 24	—
SECONDARY Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey.	5.3; 5.4; 7.1; 6.4	—
SECONDARY Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey.	3.3; 3.3; 4.4; 3.9	—
SECONDARY Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey.	35; 28; 21; 24	—
SECONDARY Number of Opioid Doses Taken During the Two Weeks After Surgery as Measured by the Post-operative Survey.	7.2; 9.5; 27.3; 23.3	—
SECONDARY 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; 0; 0; 0	—
SECONDARY 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; 0; 0; 0	—
SECONDARY Patient Health Questionnaire 8-item (PHQ-8) Score (Depression) as Measured by the Post-operative Survey.	5.1; 5.6; 7.4; 7.6	—
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)- Pediatric Anxiety - Short Form 8a Score as Measured by the Post-operative Survey.	11.2; 12.4; 15.9; 13.4	—
SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)- Sleep Disturbance - Short Form 4a Score as Measured by the Post-operative Survey.	8.4; 9.7; 12.2; 11.2	—
SECONDARY 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; 0; 1; 0	—
SECONDARY 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; 1; 0; 1	—
SECONDARY 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; 0; 3; 0	—
SECONDARY 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; 0; 4; 3	—
SECONDARY Proportion of Patients With Leftover Doses Who Disposed of Them	28; 17; 13; 17	—

Summary

This study will evaluate whether lowering the default number of doses for opioid prescriptions written in an electronic health record system can decrease opioid prescribing without causing unintended consequences such as worsened pain control.

Eligibility Criteria

Inclusion Criteria

Adolescents and young adults aged 12-25 years undergoing tonsillectomy at C.S. Mott Hospital, University Hospital, Brighton Center for Specialty Care, or Livonia Center for Specialty Care from October 2019-July 2021, excluding April-May 2020 (owing to suspension of elective procedures due to COVID-19).
Surgeon belongs to the Department of Otolaryngology at the University of Michigan Medical School
Patients are not any of the following: patients living in foster care or with a legal guardian, patients with medical complexity or developmental delays, non-English speaking patients, patients with recent suicidal ideation documented in their chart, or patients undergoing emergent tonsillectomy.

Exclusion Criteria

Patients with prescription opioid use prior to surgery
Patients undergoing additional procedures at the same time as tonsillectomy (other than minor procedures such as tympanostomy tube placement)
Patients enrolled in another study
Patients who are not prescribed opioids post-operatively at discharge
Patients who are enrolled in the Michigan Pain-control Optimization Pathway (M-POP), which includes education about pain management and a small initial opioid prescription
Patients with hospitalization with length of stay > 1 day after surgery
Patients who decline to enroll
Additional exclusion criteria for secondary analysis: Patients who do not complete the baseline and post-operative day 14 surveys

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04066829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.