NCT04066829

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

Completed NA Results posted Last updated 1 November 2022

What this trial tests

NA trial testing Default setting intervention in Tonsillectomy in 198 participants. Completed in 31 July 2021.

Timeline

1 October 2019

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	198
Start date	1 October 2019
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Default setting intervention

Conditions studied

• Tonsillectomy — all drugs for Tonsillectomy →

Sponsor

University of Michigan

Who can join

Adults 12 to 25, any sex, with Tonsillectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Doses in the Initial Discharge Opioid Prescription Primary · Day of discharge, approximately 1 day

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.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	22.3	± 7.4
Pediatric Otolaryngology Service (Post-Intervention)	16.1	± 6.5
General Otolaryngology Service (Control, Pre-Intervention)	33.7	± 20.4
General Otolaryngology Service (Control, Post-Intervention)	30.4	± 12.4

Proportion of Patients for Whom the Number of Doses in the Discharge Opioid Prescription Equals the Number of Doses in the New Default Settings Primary · Day of discharge, approximately 1 day

The 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.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	1
Pediatric Otolaryngology Service (Post-Intervention)	27
General Otolaryngology Service (Control, Pre-Intervention)	2
General Otolaryngology Service (Control, Post-Intervention)	0

Proportion of Participants Who Had at Least One Opioid Prescription Refill From University of Michigan During the Two Weeks After Surgery Primary · Day 14

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.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	10
Pediatric Otolaryngology Service (Post-Intervention)	12
General Otolaryngology Service (Control, Pre-Intervention)	25
General Otolaryngology Service (Control, Post-Intervention)	26

Proportion of Patients Who Visited or Saw a University of Michigan Provider Due to Pain During the Two Weeks After Surgery Primary · Day 14

Detailed in electronic health record. Excludes emergency department visits and hospitalizations for pain.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	2
Pediatric Otolaryngology Service (Post-Intervention)	1
General Otolaryngology Service (Control, Pre-Intervention)	0
General Otolaryngology Service (Control, Post-Intervention)	1

Proportion of Patients With at Least One Emergency Department and/or Hospitalization at University of Michigan for Pain During the Two Weeks After Surgery Primary · Day 14

Detailed in electronic health record

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	3
Pediatric Otolaryngology Service (Post-Intervention)	2
General Otolaryngology Service (Control, Pre-Intervention)	2
General Otolaryngology Service (Control, Post-Intervention)	3

Overall Satisfaction Score on Pain Control During the Two Weeks After Surgery as Measured by the Post-operative Survey. Secondary · Day 14

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

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	7.4	± 2.4
Pediatric Otolaryngology Service (Post-Intervention)	7.4	± 2.4
General Otolaryngology Service (Control, Pre-Intervention)	6.5	± 2.5
General Otolaryngology Service (Control, Post-Intervention)	6.7	± 7.0

Proportion of Patients Who Reported That Their Pain Was Well-controlled as Measured by the Post-operative Survey. Secondary · Day 14

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	32
Pediatric Otolaryngology Service (Post-Intervention)	25
General Otolaryngology Service (Control, Pre-Intervention)	11
General Otolaryngology Service (Control, Post-Intervention)	18

Proportion of Patients Whose Overall Pain Control Was Rated as Much Worse or Worse Than Expected as Measured by the Post-operative Survey. Secondary · Day 14

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

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	15
Pediatric Otolaryngology Service (Post-Intervention)	11
General Otolaryngology Service (Control, Pre-Intervention)	11
General Otolaryngology Service (Control, Post-Intervention)	18

Proportion of Patients Whose Pain Has Resolved by Day 14 After Surgery as Measured by the Post-operative Survey. Secondary · Day 14

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.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	32
Pediatric Otolaryngology Service (Post-Intervention)	34
General Otolaryngology Service (Control, Pre-Intervention)	17
General Otolaryngology Service (Control, Post-Intervention)	24

Pain in the Throat and/or Mouth Over the Past 7 Days at Its Worst as Measured by the Post-operative Survey. Secondary · Day 14

Pain control is on a scale of 0-10 with higher scores indicating more pain.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	5.3	± 2.8
Pediatric Otolaryngology Service (Post-Intervention)	5.4	± 3.2
General Otolaryngology Service (Control, Pre-Intervention)	7.1	± 2.0
General Otolaryngology Service (Control, Post-Intervention)	6.4	± 3.1

Pain in the Throat and/or Mouth Over the Past 7 Days on Average as Measured by the Post-operative Survey. Secondary · Day 14

Pain control is on a scale of 0-10 with higher scores indicating worse pain.

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	3.3	± 2.1
Pediatric Otolaryngology Service (Post-Intervention)	3.3	± 3.0
General Otolaryngology Service (Control, Pre-Intervention)	4.4	± 2.0
General Otolaryngology Service (Control, Post-Intervention)	3.9	± 2.2

Proportion of Patients With Leftover Doses of Opioids as Measured by the Post-operative Survey. Secondary · Day 14

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?

Group	Value	95% CI
Pediatric Otolaryngology Service (Pre-Intervention)	35
Pediatric Otolaryngology Service (Post-Intervention)	28
General Otolaryngology Service (Control, Pre-Intervention)	21
General Otolaryngology Service (Control, Post-Intervention)	24

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Association Between Default Number of Opioid Doses in Electronic Health Record Systems and Opioid Prescribing to Adolescents and Young Adults Undergoing Tonsillectomy.
   Chua KP, Thorne MC, Ng S, Donahue M, et al · · 2022 · cited 9× · PMID 35771572 · DOI 10.1001/jamanetworkopen.2022.19701