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NCT04955444

Opioid Use After Thyroid and Parathyroid Surgeries

Completed NA Results posted Last updated 5 September 2023
What this trial tests

NA trial testing Quality improvement bundle in Thyroidectomy in 240 participants. Completed in 31 December 2021.

Timeline
14 June 2021
Primary endpoint
31 December 2021
31 December 2021

Quick facts

Lead sponsorThe Methodist Hospital Research Institute
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposehealth services research
Enrollment240
Start date14 June 2021
Primary completion31 December 2021
Estimated completion31 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The Methodist Hospital Research Institute

Who can join

18 and older, any sex, with Thyroidectomy or Parathyroidectomy. 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.

New Opioid Discharge Prescriptions Primary · Up to 2 days

Proportion of patients who receive new opioid discharge prescriptions at discharge following a thyroidectomy or parathyroidectomy procedure. This outcome excludes continuation of previous, chronic opioid therapy.

GroupValue95% CI
Historical Control Group128
Post-implementation Group28
Opioid Discharge Prescriptions Exceeding 112.5 Oral Morphine Milligram Equivalents (MMEs) Secondary · Up to 2 days

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding the recommended dose of 112.5 oral MMEs

GroupValue95% CI
Historical Control Group52
Post-implementation Group8
Opioid Discharge Prescriptions Exceeding 5 Days Secondary · Up to 2 days

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid discharge prescriptions exceeding 5 days of therapy

GroupValue95% CI
Historical Control Group27
Post-implementation Group5
New Opioid Prescriptions From the Surgeon's Office Within 7 Days of Surgery Secondary · Up to 7 days

Proportion of thyroidectomy and parathyroidectomy postoperative patients who receive new opioid prescriptions from the surgeon's office within 7 days of surgery including discharge prescriptions. This outcome excludes continuation of previous, chronic opioid therapy.

GroupValue95% CI
Historical Control Group0
Post-implementation Group0
Opioid Prescriptions Exceeding 50 Oral MMEs/Day When New Discharge Prescriptions Are Added to Existing Opioid Therapy Secondary · Up to 2 days

Proportion of thyroidectomy and parathyroidectomy postoperative patients with opioid prescriptions exceeding 50 oral MMEs/day when new, postoperative discharge prescriptions are added to existing opioid therapy

GroupValue95% CI
Historical Control Group9
Post-implementation Group0

Sponsor's own description

Unnecessary opioid prescriptions for postoperative pain can increase the risk for new, persistent opioid use and dependence. Published literature suggests that most patients undergoing thyroid or parathyroid surgery can have their pain effectively managed without opioids following hospital discharge. The purpose of this quasi-experimental, quality improvement study is to develop, implement, and measure the impact of a quality improvement bundle that consists of (1) patient education, (2) provider education, and (3) electronic health record (EHR) enhancements. The proportion of patients who receive new opioid discharge prescriptions for pain management following thyroid or parathyroid surgery at Houston Methodist Hospital for up to 6 months following bundle implementation will be compared to a historical control group.

Publications & conference data

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

  1. Optimization of Opioid Discharge Prescriptions Following Thyroid and Parathyroid Surgery.
    Rizk E, Yuan F, Zheng F, Fink E, et al · · 2023 · cited 1× · PMID 36040827 · DOI 10.1177/01945998221121626

Verify or expand the search:

Other trials of Quality improvement bundle

Trials testing the same drug.

Other recruiting trials for Thyroidectomy

Currently open trials in the same condition.

Other The Methodist Hospital Research Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04955444.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing