Personalization of Opioid Prescription Following Orthognathic Surgery

Summary

This study aims to investigate pain management and satisfaction following orthognathic surgery, which is a type of surgery that corrects jaw and facial bone issues. This type of surgery can result in significant post-operative pain for participants, and the goal of this study is to find a way to manage this pain in a more effective and safe manner.

The study will focus on the use of opioid pain medication and will compare two groups: one group will receive a standardized prescription plan. In contrast, the other group will receive a personalized prescription with a plan to taper the opioid medication. In the end, any unused opioid will be compared at the end of the 7-day post-discharge period between the two groups. This is important because excessive opioid prescription can either be diverted to the community or can be misused leading to opioid use disorders.

Data will be collected from pre-surgery appointments, during the surgery and hospital stay, and follow-up appointments. The data collected will include participants' demographics, medical history, type of surgery, and information about the pain medication used.

The study hypothesizes that the personalized prescription plan will result in less unused medication and higher satisfaction with pain management compared to the standardized prescription plan. The study will also stratify the participants into single-jaw surgery and double-jaw surgery groups to evaluate if any differences in the outcomes are observed. This study will help to provide guidance for future pain management practices for participants undergoing orthognathic surgery. Furthermore, this study will also benefit society by providing insights into addressing the opioid crisis that is currently affecting many communities across North America.

Conditions

• Pain, Postoperative
• Orthognathic Surgery
• Opioid Use
• Patient Satisfaction
• Opioid Use Disorder

Interventions

DRUG

Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery

POP participants will be given a personalized opioid prescription with a tapering protocol based on their last inpatient 24-hour usage of opioids, obtained from the nursing medication administration record. Should a participant stay in the hospital for less than 24 hours (e.g. patient had an early discharge at 18 hours), the 24-hour in-patient opioid usage would be extrapolated from their total amount and frequency of opioid use. The participant will be provided with an instruction card with suggestions on how much opioid to take at various time points following discharge to safely taper their medication.

DRUG

Standardized dose and frequency of hydromorphone with no tapering post-orthognathic surgery

SOP participants will be given a standardized dose of hydromorphone (2-4mg orally every 6 hours), and a total amount of 40mg. No further information is provided to them with regards to their pain medication and to tapering.

Sponsors & Collaborators

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Amr Alsabbagh, DDS · Dalhousie University

• Jean-Charles Doucet, DMD, MD, MSc · Dalhousie University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-24

Primary Completion

2024-05-30

Completion

2026-05-01

Countries

• Canada

Study Locations