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Personalization of Opioid Prescription Following Orthognathic Surgery

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Minor Study completion date: May 1, 2025 to May 1, 2026v8
  2. Minor Study completion date: Jan 1, 2025 to May 1, 2025v7
  3. Minor Trial status: Recruiting to Active, Not Recruitingv6 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 201
    • Primary completion date changed from estimate of Jun 2025 to May 30, 2024
    • Study completion date: Jun 2026 to Jan 1, 2025
    • Site details revised
  4. Minor Site details revisedv5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Apr 24, 2023
    • Site details revised
    v4
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  1. Notable Phase: Not applicable to Phase 4
    • Interventions: Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery (Behavioral)… to Personalization of dose and frequency and instituting a tapering protocol of hydromorphone post-orthognathic surgery (Drug), Standardized…
    • Eligibility criteria expanded, about 13 words
    v3
  2. Minor Secondary endpoints: details revised at 2 of 4 entriesv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05708521
Lead Sponsor Nova Scotia Health Authority
Conditions
(from sponsor)
Pain, Postoperative, Orthognathic Surgery, Opioid Use, Patient Satisfaction, Opioid Use Disorder
Related terms Opioid-Related Disorders, Patient Satisfaction, Postoperative Pain
Enrollment 201 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov