Opioid Reduction Toolkit Reduces Opioids Prescribed and Consumed

Pain Clinical Trial

Official title:

Successful Implementation of an Opioid Reduction Toolkit in Pancreatectomy Patients Significantly Decreases Number of Opioids Prescribed and Consumed

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05363436
• Other study ID #: 19D.688Panc
• Status: Suspended
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators studied a baseline population of patients receiving pancreatectomies at their institution and determined how many opioid pills each patient was prescribed and how many they took. Based on this data they created a toolkit to provide to prescribers to give patients a modified number of pills. The amount prescribed and consumed was measured after intervention.

Description:

A single academic surgical department reviewed opioid treatment patterns for patients undergoing common procedures, including open pancreatectomy, and an opioid reduction toolkit using the data collected was created. Providers were educated on the use of the toolkit and it was implemented as a standard of practice. Data were collected on pancreatectomy patients via telephone interview (performed at 2 weeks post-op) and by reviewing the state prescription drug monitoring program. Outcome variables included morphine milliequivalents (MME) of pills prescribed, MME of pills consumed, number of patients aware of proper unused pill disposal, number of patients requesting refills, and pain scores. Categorical and continuous outcomes were compared within and between groups.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 159
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age > 18

• Being scheduled for an outpatient elective pancreatectomy

Exclusion Criteria:

• Urgent/emergent status

• Concomitant procedure being performed at time of pancreatectomy

Related Conditions & MeSH terms

• Opioid Abuse
• Opioid Misuse
• Opioid-Related Disorders
• Pain

Intervention

Drug:
• Oxycodone
Providers had to prescribe 15 oxycodone pills to each patient discharge

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of opioid pills reported being taken by the patient	Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals	14 days
Primary	Number of opioid pills being prescribed	Discharge paperwork and prescription information will be searched to determine the number of opioid pills were provided to the patient at discharge	14 days